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BackgroundTo control the COVID-19 pandemic, people should adopt protective behaviors at home (self-isolation, social distancing, putting shopping and packages aside, wearing face coverings, cleaning and disinfecting, and handwashing). There is currently limited support to help individuals conduct these behaviors. ObjectiveThis study aims to report current household infection control behaviors in the United Kingdom and examine how they might be improved. MethodsThis was a pragmatic cross-sectional observational study of anonymous participant data from Germ Defence between May 6-24, 2020. Germ Defence is an open-access fully automated website providing behavioral advice for infection control within households. A total of 28,285 users sought advice from four website pathways based on household status (advice to protect themselves generally, to protect others if the user was showing symptoms, to protect themselves if household members were showing symptoms, and to protect a household member who is at high risk). Users reported current infection control behaviors within the home and intentions to change these behaviors. ResultsCurrent behaviors varied across all infection control measures but were between sometimes (face covering: mean 1.61, SD 1.19; social distancing: mean 2.40, SD 1.22; isolating: mean 2.78, SD 1.29; putting packages and shopping aside: mean 2.75, SD 1.55) and quite often (cleaning and disinfecting: mean 3.17, SD 1.18), except for handwashing (very often: mean 4.00, SD 1.03). Behaviors were similar regardless of the website pathway used. After using Germ Defence, users recorded intentions to improve infection control behavior across all website pathways and for all behaviors (overall average infection control score mean difference 0.30, 95% CI 0.29-0.31). ConclusionsSelf-reported infection control behaviors other than handwashing are lower than is optimal for infection prevention, although handwashing is much higher. Advice using behavior change techniques in Germ Defence led to intentions to improve these behaviors. Promoting Germ Defence within national and local public health and primary care guidance could reduce COVID-19 transmission.

BackgroundIncreasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults. ObjectiveIn this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial. MethodsIn the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463). ResultsResults will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021. ConclusionsThe findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial. Trial RegistrationInternational Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980 International Registered Report Identifier (IRRID)DERR1-10.2196/18929

BackgroundChildhood eczema, or childhood atopic dermatitis, causes significant distress to children and their families through sleep disturbance and itch. The main cause of treatment failure is nonuse of prescribed treatments. ObjectiveThe objective of this study was to develop and test a Web-based intervention to support families of children with eczema, and to explore whether support from a health care professional (HCP) is necessary to engage participants with the intervention. MethodsWe followed the PRECEDE-PROCEED model: regular emollient use was the target behavior we were seeking to promote and we identified potential techniques to influence this. LifeGuide software was used to write the intervention website. Carers of children with eczema were invited through primary care mail-out and randomized to 3 groups: (1) website only, (2) website plus HCP support, or (3) usual care. Patient-Oriented Eczema Measure (POEM) scores were measured online by carer report at baseline and at 12 weeks. Qualitative interviews were carried out with 13 HCPs (primarily practice nurses) and 26 participants to explore their experiences of taking part in the study. ResultsA total of 143 carers were recruited through 31 practices. We found a decrease of ≥2 in follow-up compared with baseline POEM score in 23 of 42 (55%) participants in the website only group, 16 of 49 (33%) in the usual care group, and 18 of 47 (38%) in the website plus HCP group. Website use data showed that 75 of 93 (81%) participants allocated to the website groups completed the core modules, but less than half used other key components (videos: 35%; regular text reminders: 39%). There were no consistent differences in website use between the website only or the website plus HCP groups. Qualitative feedback showed that most HCPs had initial concerns about providing support for eczema self-care because this was not a condition that they felt expert in. However, HCPs reported productive consultations and that they found it helpful to use the website in consultations, while observing that some participants seemed to need more support than others. Qualitative interviews with participants suggested that HCP support was valued highly only by a minority, generally those who were less confident in their management of eczema or less confident using the Internet. ConclusionsOur pilot trial demonstrated the potential for greater improvements in POEM scores in both website intervention groups and that a full-scale trial is feasible. Such a trial would quantify the effectiveness and cost-effectiveness of this intervention to determine whether it should be widely promoted to families of children with newly diagnosed eczema. In this study population, HCP support was not strongly valued by participants and did not lead to better outcomes or website use than use of the Web-based intervention alone. Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 98560867; http://www.controlled-trials.com/ISRCTN98560867 (Archived by WebCite at http://www.webcitation.org/6NcxvMtgN).

Background Antimicrobial resistance is a global health threat. Antibiotics are commonly prescribed for children with uncomplicated lower respiratory tract infections, but there is little randomised evidence to support the effectiveness of antibiotics in treating these infections, either overall or relating to key clinical subgroups in which antibiotic prescribing is common (chest signs; fever; physician rating of unwell; sputum/rattly chest; shortness of breath). Objectives To estimate the clinical effectiveness and cost-effectiveness of amoxicillin for uncomplicated lower respiratory tract infections in children both overall and in clinical subgroups. Design Placebo-controlled trial with qualitative, observational and cost-effectiveness studies. Setting UK general practices. Participants Children aged 1–12 years with acute uncomplicated lower respiratory tract infections. Outcomes The primary outcome was the duration in days of symptoms rated moderately bad or worse (measured using a validated diary). Secondary outcomes were symptom severity on days 2–4 (0 = no problem to 6 = as bad as it could be); symptom duration until very little/no problem; reconsultations for new or worsening symptoms; complications; side effects; and resource use. Methods Children were randomised to receive 50 mg/kg/day of oral amoxicillin in divided doses for 7 days, or placebo using pre-prepared packs, using computer-generated random numbers by an independent statistician. Children who were not randomised could participate in a parallel observational study. Semistructured telephone interviews explored the views of 16 parents and 14 clinicians, and the data were analysed using thematic analysis. Throat swabs were analysed using multiplex polymerase chain reaction. Results A total of 432 children were randomised (antibiotics, n = 221; placebo, n = 211). The primary analysis imputed missing data for 115 children. The duration of moderately bad symptoms was similar in the antibiotic and placebo groups overall (median of 5 and 6 days, respectively; hazard ratio 1.13, 95% confidence interval 0.90 to 1.42), with similar results for subgroups, and when including antibiotic prescription data from the 326 children in the observational study. Reconsultations for new or worsening symptoms (29.7% and 38.2%, respectively; risk ratio 0.80, 95% confidence interval 0.58 to 1.05), illness progression requiring hospital assessment or admission (2.4% vs. 2.0%) and side effects (38% vs. 34%) were similar in the two groups. Complete-case (n = 317) and per-protocol (n = 185) analyses were similar, and the presence of bacteria did not mediate antibiotic effectiveness. NHS costs per child were slightly higher (antibiotics, £29; placebo, £26), with no difference in non-NHS costs (antibiotics, £33; placebo, £33). A model predicting complications (with seven variables: baseline severity, difference in respiratory rate from normal for age, duration of prior illness, oxygen saturation, sputum/rattly chest, passing urine less often, and diarrhoea) had good discrimination (bootstrapped area under the receiver operator curve 0.83) and calibration. Parents found it difficult to interpret symptoms and signs, used the sounds of the child’s cough to judge the severity of illness, and commonly consulted to receive a clinical examination and reassurance. Parents acknowledged that antibiotics should be used only when ‘necessary’, and clinicians noted a reduction in parents’ expectations for antibiotics. Limitations The study was underpowered to detect small benefits in key subgroups. Conclusion Amoxicillin for uncomplicated lower respiratory tract infections in children is unlikely to be clinically effective or to reduce health or societal costs. Parents need better access to information, as well as clear communication about the self-management of their child’s illness and safety-netting. Future work The data can be incorporated in the Cochrane review and individual patient data meta-analysis. Trial registration This trial is registered as ISRCTN79914298. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 9. See the NIHR Journals Library website for further project information. Plain language summary Background Children are commonly prescribed antibiotics for chest infections, but such infections are becoming resistant to antibiotics, and it is not clear if antibiotics work in treating them. Methods A total of 432 children who saw their general practitioner with a chest infection were given either an antibiotic (amoxicillin) or a placebo (no antibiotic) for 7 days. Symptom diaries documented the infection’s duration and its side effects. Children not in the placebo study were able to participate in another study that documented the same outcomes (an ‘observational study’). We interviewed parents, doctors and nurses about their observations and concerns. Our patient and public involvement and engagement work with parents indicated that a 3-day symptom reduction was required to justify giving antibiotics. Results After seeing the doctor, parents whose children received antibiotics rated infective symptoms as moderately bad or worse for 5 days, and parents whose children received the placebo rated these for 6 days. Side effects and complications were similar in the two groups. Findings were similar when including the results of the observational study, and for children in whose chest the doctor could hear wheeze or rattles; who had fever; who were rated by the doctor as more unwell, who were short of breath, or who had had bacteria detected in the throat. The costs to the NHS per child were similar (antibiotics, £29; placebo, £26), and the wider costs to society were the same (antibiotics, £33; placebo, £33). Parents found it difficult to interpret their child’s symptoms, and commonly used the sound of the cough to judge severity. Parents commonly consulted to receive an examination and reassurance, and accepted that antibiotics should be used only when ‘necessary’. Clinicians noted a reduction in parents’ expectations for antibiotics. Conclusion Amoxicillin for chest infections in children is unlikely to be effective. General practitioners should support parents to self-manage at home and give clear communication about when and how to seek medical help if they continue to be concerned. Scientific summary Background Antimicrobial resistance (AMR) is a global public health threat. Antibiotics are very commonly prescribed for children presenting with uncomplicated lower respiratory tract infection, but there is little randomised evidence of the effectiveness of antibiotics for treating these, either overall or among key clinical subgroups. Objective The objective was to undertake a trial of antibiotics for children presenting with lower respiratory tract infection in primary care, with a parallel observational study. Aims The aims were to: 1.estimate the effectiveness of amoxicillin overall and in key clinical subgroups of children presenting with uncomplicated (non-pneumonic) lower respiratory tract infection in primary care 2.estimate the cost-effectiveness of antibiotics overall in children presenting with uncomplicated (non-pneumonic) lower respiratory tract infection in primary care 3.explore the estimates of effectiveness according to key pathophysiological subgroups (the presence of bacterial pathogens) 4.explore which variables predict poor prognosis and develop a prediction model for poor prognosis 5.explore the views of parents and clinicians regarding management of children and participation in the trial. Design This was a placebo-controlled trial with qualitative research and health economic analysis, and a parallel observational cohort. Setting UK general practices. Participants Participants were children aged between 6 months and 12 years presenting to primary care with an acute lower respiratory tract infection, defined as one in which an acute cough is the predominant symptom and judged by the general practitioner (GP) to be infective in origin, lasting < 21 days, and with other symptoms or signs localising to the lower respiratory tract (shortness of breath, sputum, pain), and in whom pneumonia was not suspected clinically. Outcomes The primary outcome was the duration in days of symptoms rated moderately bad or worse (measured using a validated diary). The secondary outcomes were symptom severity on days 2–4 (0 = no problem to 6 = as bad as it could be); symptom duration until very little/no problem; reconsultations for new or worsening symptoms; progression of illness sufficient to require hospital assessment; side effects; and resource use. Ethics The protocol was approved by the South West – Central Bristol Research Ethics Committee (reference 15/SW/0300). Methods Children were randomised to receive 50 mg/kg/day oral amoxicillin in divided doses for 7 days, or placebo, using pre-prepared packs randomised by an independent statistician using computer-generated random numbers. Children whom clinicians were unwilling to randomise or parents who were unwilling for their child to be randomised were invited to participate in an observational study in which the same data as in the trial were collected. The revised target sample size (agreed with the Trial Steering Committee, the Data Monitoring and Ethics Committee and the funder) to detect an important clinical difference of 3 days in symptoms duration was 298 participants for 80% power and 398 participants for 90% power. Semistructured interviews were used to explore the views of management and the decisions to participate in the trial. Parents were purposefully sampled by whether they took part in the trial or the observational study, and by practice. Clinicians who recruited participants into the study were also invited to take part in a telephone interview. The interviews were analysed using thematic analysis. Throat swabs were analysed for the presence of bacteria and viruses by multiplex polymerase chain reaction. Statistical analysis Cox regression was used for the primary outcome and for total symptom duration, adjusting for age, baseline symptom severity, prior duration of illness and comorbidity. Linear regression was used for symptom severity, and logistic regression was used for reconsultation, progression of illness and side effects, adjusting for the same baseline covariates as in the primary analysis. Analysis was by intention to treat, as randomised regardless of non-adherence or protocol deviations. Multiple imputation was used as the primary analysis, comprising all variables from the analysis model and any predictors of missingness, and using 100 imputations. Prespecified subgroup analyses were carried out on chest signs, sputum/rattly chest, history of fever, physician rating of unwell, shortness of breath, oxygen saturation below 95%, and STARWAVe clinical prediction rule for hospitalisation. For the observational data set, stratification by propensity scores was used to control for confounding by indication, and the data were merged with the trial data set to facilitate more powerful analyses. A logistic regression model was built to predict the progression of illness, and discrimination was assessed using estimates of area under the receiver operator curve that were bootstrapped for internal validation. Health economic analysis Both cost-effectiveness (in GBP per unit of primary outcome) and cost per quality-adjusted life-year (QALY) were estimated. The base case took an NHS perspective, but some non-NHS costs were also included (remedies and time off work). Resource use data were collected by a notes review in primary care supplemented by the diary. Unit costs of primary care consultation, community services, outpatient visits and accident and emergency attendances were costed based on the Personal Social Services Research Unit. National reference costs were used to cost hospital stay based on corresponding diagnostic categories. Medications were priced based on the British National Formulary. All costs were based on 2019 prices. QALYs were based on the EQ-5D-Y (EuroQol-5 Dimensions Youth), collected weekly, and on the recommended national tariff. Trial results A total of 432 children were randomised (antibiotics, n = 221; placebo, n = 211). The duration of moderately bad symptoms was similar in the two groups [median 5 vs. 6 days, respectively; hazard ratio (HR) 1.13, 95% confidence interval (CI) 0.90 to 1.42]. Return with new or worsening symptoms (29.7% vs. 38.2%; risk ratio 0.80, 95% CI 0.58 to 1.05), progression of illness requiring hospital assessment (2.4% vs 2.0%) and side effects (38% vs. 34%) were also similar in the two groups. A small difference in mean symptom severity on days 2–4 (1.8 vs. 2.1 points; difference 0.28 points, 95% CI 0.04 to 0.51) is unlikely to be clinically meaningful. No differences were seen for the primary outcome in the five prespecified clinical subgroups in which antibiotic prescribing is common: chest signs subgroup (antibiotics 6 days vs. placebo 6 days; HR 0.97, 95% CI 0.65 to 1.43), sputum/rattly chest (5 vs. 7 days; 1.16, 95% CI 0.83 to 1.64), fever (5 vs. 6 days; 1.23, 95% CI 0.88 to 1.73), physician rating of unwell (5 vs. 6 days; 1.25, 95% CI 0.85 to 1.83) and shortness of breath (5 vs. 6 days; 1.13, 95% CI 0.72 to 1.77). There was also no evidence that the presence of bacteria in the throat swab mediated antibiotic effectiveness. Estimates from complete cases (n = 317) were very similar, as were estimates from a per-protocol analysis for children taking 11 or more of the of 15 doses in the first 5 days. NHS costs per child were slightly higher with antibiotics (antibiotic, £29; placebo, £26) and non-NHS costs were the same (antibiotics, £33; placebo, £33), but QALY data were too incomplete for robust imputation. The incremental cost per QALY (incremental cost-effectiveness ratio) was £30,851 (95% CI –£73,639 to £109,429) based on estimates from the means of complete cases and £6417 (95% CI –£12,240 to £20,535) based on the estimates using imputed data. Observational study A total of 326 children were recruited to the observational study. The estimate of benefit of antibiotics for the primary outcome was similar to that in the trial (HR 1.16, 95% CI 0.95 to 1.41). A prognostic model to predict the progression of illness consisting of seven variables (baseline severity, difference in respiratory rate from normal for age, duration of prior illness, oxygen saturation, sputum/rattly chest, passing urine less often and diarrhoea) had good discrimination (bootstrapped area under the receiver operator curve 0.85) and calibration, and a three-item model (respiratory rate, oxygen saturation, sputum/rattly chest) also performed well (area under the receiver operator curve 0.81). Qualitative results Thirty semistructured telephone interviews were conducted with 16 parents and 14 clinicians. Parents found it difficult to interpret the symptoms and signs, and commonly used the sounds of the cough to judge severity, which highlights the need to provide better information to support parents. Many parents said that the main reason for consulting was to receive a clinical examination and reassurance regarding illness severity. Parents acknowledged that antibiotics should be used only when ‘necessary’, and many of the clinicians also noted a shift in parents’ expectations about antibiotics and that they were satisfied with a clinical assessment, reassurance and advice. Decisions to take part in the trial were influenced by the perceived risks associated with taking a placebo compared with immediate antibiotics, and with taking antibiotics unnecessarily. Clear communication about the self-management of their child’s illness and ‘safety-netting’ (information on the natural course of the illness and advice about when it might be necessary to reconsult) were identified as important when implementing ‘no antibiotic’ prescribing strategies to reassure parents and to support prescribing decisions. Limitations The study was underpowered to detect small benefits in the key clinical subgroups. The trial included children who were more unwell than those in recent large generalisable cohorts, which suggests that, if anything, the benefit of antibiotics has been overestimated. Given the very large numbers of missing data, the imputed estimates in the economic analysis must be viewed with caution. If the costs of AMR were included, then these estimates of cost-effectiveness would worsen. Conclusions Implications for clinical care Amoxicillin for uncomplicated chest infections in children makes little difference to symptom burden or to health or societal costs. Better access to information is needed to support parents’ decision-making, as is clear clinician communication about the self-management of their child’s illness and safety-netting. A prognostic score using variables that can be collected very easily during consultations can be used to identify children who are at low risk of illness progression. Implications for future research •The data can be incorporated in a Cochrane review and an individual patient data meta-analysis. •Further work on the incremental QALY gain from antibiotics is needed, assessing a range of models and their implications when imputing missing QALY data, and better evidence is needed about how to incorporate AMR resource implications in modelling. •The prognostic score should be externally validated and could be developed as an app with automated outputs, and thereafter used as a tool to reduce antibiotic prescribing for antimicrobial stewardship interventions. Trial registration This trial is registered as ISRCTN79914298. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 9. See the NIHR Journals Library website for further project information.

Asthma outcomes remain suboptimal, despite effective pharmacotherapy. Psychological dysfunction (such as anxiety) is common, and associated with poorer outcomes. We evaluated a digital mindfulness programme as an intervention to improve asthma-related quality of life for primary care patients, in a prospectively registered randomized-controlled feasibility study. We offered 'Headspace', a widely-used digital mindfulness intervention, to adults with asthma through 16 UK GP practices. Participants were randomized on a 2:1 basis to the mindfulness intervention, or waitlist control. Participants completed questionnaires (including asthma symptom control, asthma-related quality of life, anxiety, depression) at baseline, 6-week and 3-month follow-up. 116 participants completed primary outcomes at 3-month follow-up: intervention 73 (79%), control 43 (84%). Compared to baseline, the intervention group but not the control group reported significantly improved asthma-related quality of life, with a between-group difference favoring the intervention group that was not significant (Mean difference = 0.15, 95%CI - 0.13 to 0.42). Intervention use varied (ranging from 0 to 192 times) but was generally high. Digital mindfulness interventions are feasible and acceptable adjunct treatments for mild and moderate asthma to target quality of life. Further research should adapt 'generic' mindfulness-based stress-reduction to maximize effectiveness for asthma, and validate our findings in a fully-powered randomized controlled trial. Trial registration Prospectively registered: ISRCTN52212323., Author(s): Ben Ainsworth [sup.1] [sup.2] , Sabina Stanescu [sup.3] , Beth Stuart [sup.4] , Daniel Russell [sup.5] , Megan Liddiard [sup.4] , Ratko Djukanovic [sup.2] [sup.6] , Mike Thomas [sup.4] [...]

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. [ABSTRACT FROM AUTHOR]

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: 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 was 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. [ABSTRACT FROM AUTHOR]

Background The Harmonising Outcome Measures for Eczema (HOME) initiative has agreed upon the Core Outcome Set (COS) for use in atopic dermatitis (AD) clinical trials, but additional guidance is needed to maximize its uptake. Objectives To provide answers to some of the commonly asked questions about using the HOME COS; to provide data to help with the interpretation of trial results; and to support sample size calculations for future trials. Methods and results We provide practical guidance on the use of the HOME COS for investigators planning clinical trials in patients with AD. It answers some of the common questions about using the HOME COS, how to access the outcome measurement instruments, what training/resources are needed to use them appropriately and clarifies when the COS is applicable. We also provide exemplar data to inform sample size calculations for eczema trials and encourage standardized data collection and reporting of the COS. Conclusions By encouraging adoption of the COS and facilitating consistent reporting of outcome data, it is hoped that the results of eczema trials will be more comprehensive and readily combined in meta-analyses and that patient care will subsequently be improved. [ABSTRACT FROM AUTHOR]

Background: Active surveillance (AS) for prostate cancer (PCa) is a monitoring pathway for men with low-grade, slow growing PCa and aims to delay or avoid active treatment by treating only in the case of disease progression. Experiences of this pathway vary but living with an untreated cancer can have a negative psychological impact on both the patient and their significant other (SO). Literature suggests partners are the primary source of support for men on AS, and therefore it is important to consider SO experiences alongside those of the patient. To the best of our knowledge this is the first UK-based qualitative review looking specifically at experiences of AS for both men with PCa and their SOs. Methods: MEDLINE (Ovid), EMBASE, PsychINFO, CINAHL and Cochrane Library were searched for literature reporting qualitative experiences of AS for PCa for either men on AS or SOs (or both). 2769 records were identified and screened, with 28 meeting the eligibility criteria. Qualitative data were synthesised and included men on AS (n = 428), and SOs (n = 51). Results: Experiences of the AS pathway vary but reports of uncertainty and anxiety were present in the accounts of both men on AS and SOs. SOs are intertwined throughout every part of the PCa journey, and couples presented as a unit that were on AS together. Both patients and SOs expressed a need for more support, and highly valued peer support. Despite this finding, men expressed a dislike towards 'support groups'. Conclusions: Increased recognition in clinical practice of SO involvement in AS is needed. Further research is required to explore the specific types of support that would be most acceptable to this population to address the unmet support needs uncovered in this review. [ABSTRACT FROM AUTHOR]