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Background Coronavirus disease 2019 (COVID-19) has exposed the disproportionate effects of pandemics on frontline workers and the ethical imperative to provide effective prophylaxis. We present a model for a pragmatic randomised controlled trial (RCT) that utilises Bayesian methods to rapidly determine the efficacy or futility of a prophylactic agent. Methods We initially planned to undertake a multicentre, phase III, parallel-group, open-label RCT, to determine if hydroxychloroquine (HCQ) taken once a week was effective in preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in healthcare workers (HCW) aged ≥ 18 years in New Zealand (NZ) and Ireland. Participants were to be randomised 2:1 to either HCQ (800 mg stat then 400 mg weekly) or no prophylaxis. The primary endpoint was time to Nucleic Acid Amplification Test-proven SARS-CoV-2 infection. Secondary outcome variables included mortality, hospitalisation, intensive care unit admissions and length of mechanical ventilation. The trial had no fixed sample size or duration of intervention. Bayesian adaptive analyses were planned to occur fortnightly, commencing with a weakly informative prior for the no prophylaxis group hazard rate and a moderately informative prior on the intervention log hazard ratio centred on ‘no effect’. Stopping for expected success would be executed if the intervention had a greater than 0.975 posterior probability of reducing the risk of SARS-CoV-2 infection by more than 10%. Final success would be declared if, after completion of 8 weeks of follow-up (reflecting the long half-life of HCQ), the prophylaxis had at least a 0.95 posterior probability of reducing the risk of SARS-CoV-2 infection by more than 10%. Futility would be declared if HCQ was shown to have less than a 0.10 posterior probability of reducing acquisition of SARS-CoV-2 infection by more than 20%. Discussion This study did not begin recruitment due to the marked reduction in COVID-19 cases in NZ and concerns regarding the efficacy and risks of HCQ treatment in COVID-19. Nonetheless, the model presented can be easily adapted for other potential prophylactic agents and pathogens, and pre-established collaborative models like this should be shared and incorporated into future pandemic preparedness planning. Trial registration The decision not to proceed with the study was made before trial registration occurred.

Healthcare research is traditionally published in academic papers, coded in scientific language, and locked behind paywalls - an inaccessible form for many. Sharing research results with participants and the public in an appropriate, accessible manner, is an ethical practice directed in research guidance. Evidence-based recommendations for the medium used are scant, but science communication advice advocates principles which may be fulfilled well by the medium of comics. We report a randomised crossover study conducted online, comparing participant preferences for research results shared in the medium of a comic, a traditional lay text summary, and the control approach of a scientific abstract. 1236 respondents read all three summaries and ranked their most and least preferred formats. For the most preferred summary, the comic was chosen by 716 (57.9%), lay summary by 321 (26.0%), and scientific abstract by 199 (16.1%) respondents. For the least preferred summary the scientific abstract was chosen by 614 (49.7%), lay summary by 380 (30.7%) and comic by 242 (19.6%). Review of free-text responses identified key reasons for the majority preferring the comic over the others, which included finding this easier to read and understand, more enjoyable to consume, and more satisfactory as a medium of communication.

To synthesize the qualitative evidence of the views and experiences of people living with dementia, family carers, and practitioners on practice related to nutrition and hydration of people living with dementia who are nearing end of life.Systematic review and narrative synthesis of qualitative studies.MEDLINE, Embase, PsycINFO, CINAHL.Databases were searched for qualitative studies from January 2000-February 2020. Quantitative studies, or studies reporting on biological mechanisms, assessments, scales or diagnostic tools were excluded. Results were synthesized using a narrative synthesis approach with thematic analysis.Twenty studies were included; 15 explored the views of practitioners working with people living with dementia in long-term care settings or in hospitals. Four themes were developed: challenges of supporting nutrition and hydration; balancing the views of all parties involved with 'the right thing to do'; national context and sociocultural influences; and strategies to support nutrition and hydration near the end of life in dementia.The complexity of supporting nutrition and hydration near the end of life for someone living with dementia relates to national context, lack of knowledge, and limited planning while the person can communicate.This review summarizes practitioners and families' experiences and highlights the need to include people living with dementia in studies to help understand their views and preferences about nutrition and hydration near the end of life; and those of their families supporting them in the community. The review findings are relevant to multidisciplinary teams who can learn from strategies to help with nutrition and hydration decisions and support.目的: 综合痴呆患者、家庭护理员以及执业医师对与痴呆患者临终前的营养和水分补充相关实践的观点和经验的定性证据。 设计: 对定性研究进行系统评估和叙事综合。 数据来源: MEDLINE、Embase、PsycINFO和CINAHL。 评估方法: 对数据库自2000年1月至2020年2月期间的数据进行检索。不包括定量研究或生物机制的研究报告、评估、量表或诊断工具。使用叙事综合方法和主题分析,以综合汇总结果。 结果: 共纳入20项研究。其中,15项探讨了在长期护理环境或医院为痴呆患者服务的执业医师的观点。其中,4项主题探讨了:提供营养和水分补充所面临的挑战;平衡‘正确做法’涉及的各方观点;国家背景和社会文化影响;以及为痴呆患者在临终前提供营养和水分补充的策略。 结论: 为痴呆患者在临终前提供营养和水分补充的复杂性,与国家背景、知识匮乏和在患者可以交流时的有限规划有关。 影响: 本评估概述了执业医师和家庭的经验,强调了将痴呆患者纳入研究的必要性,以帮助理解他们在临终时的观点和对营养和水分补充的偏好;以及那些在社区中支持他们的家庭。评估研究结果与多个专业团队有关,其可从策略中进行学习,以帮助做出营养和水分补充的决定和支持。.

BACKGROUND AND PURPOSE Advance care planning allows people to plan for their future care needs and can include medical, psychological and social aspects. However, little is known on the use, experience of and attitudes towards advance care planning in patients with parkinsonian disorders, their family carers and healthcare professionals. METHODS A systematic search of online databases was conducted in April 2019 using a narrative synthesis approach with thematic analysis and tabulation to synthesize the findings. RESULTS In all, 507 articles were identified and 27 were included. There were five overarching themes: (i) what is involved in advance care planning discussions, (ii) when and how advance care planning discussions are initiated, (iii) barriers to advance care planning, (iv) the role of healthcare professionals and (v) the role of the family carer. This evidence was used to highlight eight effective components to support optimal advance care planning in parkinsonian disorders: advance care planning discussions should be individualized in content, timing and approach; patients should be invited to discuss advance care planning early and regularly; palliative care services should be introduced early; a skilled professional should deliver advance care planning; support to family carers should be offered in the advance care planning process; healthcare professionals should be educated on parkinsonian disorders and palliative care; advance care planning should be clearly documented and shared with relevant services; and healthcare professionals should be enabled to conduct effective advance care planning. CONCLUSIONS These components can inform best practice in advance care planning in patients with parkinsonian disorders.

Objectives(1) Assess the distribution of skin-to-deltoid-muscle distance (SDMD) at the deltoid intramuscular (IM) injection site; (2) its relationship with demographic and anthropometric variables and (3) Consider the findings in relation to clinical guidance on IM injection, such as COVID-19 vaccines.DesignSystematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Data sourcesMEDLINE, EMBASE, ClinicalTrials.gov, Cochrane Library, CINAHL and SCOPUS between June and July 2021 with no publication date limit.Eligibility criteriaStudies reporting measurements of the SDMD in living adults aged 16 years and older, at the deltoid IM injection site, published in English were considered.Data extraction and synthesisTwo independent reviewers performed each stage of screening, data extraction and quality assessments using the Joanna Briggs Institute Critical Appraisal Checklist for analytical cross sectional studies.Results16 105 papers were identified, of which 11 studies were suitable for review, representing 1414 participants. Heterogeneity in the definition of the deltoid IM injection site, locations measured and methods of measurement precluded meta-analysis. Evidence from ultrasound SDMD measurements demonstrated some patients in all but ‘underweight’ body mass index (BMI) categories, may require needles longer than 25 mm for successful IM injection. Calliper measurements overestimated SDMD compared with ultrasound. Female sex, higher BMI categories and greater weight in women were associated with greater SDMD.ConclusionsThe reviewed evidence was insufficient to inform definitive needle length ‘cut points’ for IM injection based on demographic or anthropomorphic variables. Contemporary clinical guidance currently based on this evidence, including the site of injection and choice of needle length, may result in subcutaneous administration in a small proportion of recipients, particularly if obese or of female sex.PROSPERO registration numberCRD42021264625.

Background Both inadequate and excessive administration of oxygen to acutely unwell patients results in risk of harm. Guidelines recommend titration of oxygen to achieve a target oxygen saturation (SpO2) range. Information regarding whether this is being achieved is limited. Methods In this two-centre non-interventional study we used continuous pulse oximetry in acutely unwell medical patients over a 24-h period to determine the proportion of time spent with SpO2 within the prescribed target range and whether this is influenced by the target range, age, care in a high-dependency area and the number of oxygen adjustments. Results Eighty participants were included in the analysis. The mean (SD) proportion of time spent in target range was 55.6% (23.6), this was lower in those with a reduced hypercapnic target range (88–92% or below) compared to those with a range of 92–96%; difference − 13.1% (95% CI − 3.0 to − 23.2), P = 0.012. The proportion of time spent above range was 16.2% (22.9); this was higher in those with a reduced hypercapnic range; difference 21.6% (31.4 to 12), P P = 0.02. Conclusions Medical patients receiving oxygen in a ward setting spend significant periods of time with SpO2 both above and below the prescribed target range while receiving oxygen therapy.

Background Asthma is the most common chronic disease in children, many of whom are managed solely with a short-acting β2-agonist (SABA). In adults, the evidence that budesonide-formoterol as sole reliever therapy markedly reduces the risk of severe exacerbations compared with SABA alone has contributed to the Global Initiative for Asthma recommending against SABA monotherapy in this population. The current lack of evidence in children means it is unknown whether these findings are also relevant to this demographic. High-quality randomised controlled trials (RCTs) are needed. Objective The aim of this study is to determine the efficacy and safety of as-needed budesonide-formoterol therapy compared with as-needed salbutamol in children aged 5 to 15 years with mild asthma, who only use a SABA. Methods A 52-week, open-label, parallel group, phase III RCT will recruit 380 children aged 5 to 15 years with mild asthma. Participants will be randomised 1:1 to either budesonide-formoterol (Symbicort Rapihaler®) 50/3 µg, two actuations as needed, or salbutamol (Ventolin®) 100 µg, two actuations as needed. The primary outcome is asthma attacks as rate per participant per year. Secondary outcomes assess asthma control, lung function, exhaled nitric oxide and treatment step change. A cost-effectiveness analysis is also planned. Conclusion This is the first RCT to assess the safety and efficacy of as-needed budesonide-formoterol in children with mild asthma. The results will provide a much-needed evidence base for the treatment of mild asthma in children., This protocol describes the first randomised controlled trial to investigate the efficacy and safety of budesonide/formoterol as sole reliever therapy for children with mild asthma, providing urgently needed evidence in this population https://bit.ly/35v0R3Z

BackgroundIn randomised controlled trials, as-needed inhaled corticosteroid (ICS)-formoterol reliever therapy reduces severe exacerbation risk compared with maintenance ICS plus short-acting beta2-agonist (SABA) reliever in adolescent and adult asthma, but results in slightly worse control of asthma symptoms, as measured by mean Asthma Control Questionnaire-5 (ACQ-5) score.ObjectiveTo assess the levels and changes in asthma control for as-needed budesonide–formoterol versus maintenance budesonide plus SABA in post hoc analyses from the Novel START and PRACTICAL clinical trials.MethodsThe number and proportion of participants at study end in each ACQ-5 category (‘well-controlled’, ‘partly controlled’ or ‘inadequately controlled’ symptoms), and in each responder category based on the minimal clinically important difference for ACQ-5 of 0.5 (improved, no change and worse) with as-needed budesonide–formoterol and maintenance budesonide plus SABA treatment were calculated.ResultsWith last observation carried forwards, 189/214 (88.3%) and 354/434 (81.6%) of patients in the budesonide–formoterol group had ‘well-controlled’ or ‘partly controlled’ symptoms at the end of the study, vs 183/214 (85.5%) and 358/431 (83.1%) in the budesonide maintenance group, for Novel START and PRACTICAL, respectively. The proportion of patients whose symptom control was either improved or unchanged from baseline was 190/214 (88.8%) and 368/434 (84.8%) for budesonide–formoterol, vs 185/214 (86.4%) and 376/431 (87.2%) for maintenance budesonide, in Novel START and PRACTICAL respectively.ConclusionsThere were no clinically important differences in the proportions of patients with ‘well-controlled’ or ‘partly controlled’ asthma symptoms, or proportions who improved or maintained their level of control, with as-needed budesonide–formoterol versus maintenance budesonide plus SABA.

Background The Global Initiative for Asthma recommends as-needed inhaled corticosteroid (ICS)-formoterol as an alternative to maintenance ICS plus short-acting β2-agonist (SABA) reliever at step 2 of its stepwise treatment algorithm. Our aim was to assess the efficacy and safety of these two treatment regimens, with a focus on prevention of severe exacerbation. Methods We performed a systematic review and meta-analysis of all randomised controlled trials (RCTs) comparing as-needed ICS-formoterol with maintenance ICS plus SABA. MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and Clinicaltrials.gov were searched from database inception to 12 December 2019. The primary outcome was time to first severe exacerbation. RCTs were excluded if they used as-needed budesonide-formoterol as part of a maintenance and reliever regimen, or did not report on severe exacerbations. The review is registered with PROSPERO (identifier number CRD42020154680). Results Four RCTs (n=8065 participants) were included in the analysis. As-needed ICS-formoterol was associated with a prolonged time to first severe exacerbation (hazard ratio 0.85, 95% CI 0.73–1.00; p=0.048) and reduced daily ICS dose (mean difference −177.3 μg, 95% CI −182.2–−172.4 μg). Asthma symptom control was worse in the as-needed group (Asthma Control Questionnaire-5 mean difference 0.12, 95% CI 0.09–0.14), although this did not meet the minimal clinically important difference of 0.50 units. There was no significant difference in serious adverse events (OR 1.07, 95% CI 0.84–1.36). Conclusion As-needed ICS-formoterol offers a therapeutic alternative to maintenance low-dose ICS plus SABA in asthma and may be the preferred option when prevention of severe exacerbation is the primary aim of treatment., As-needed low-dose ICS-formoterol prolongs time to first severe asthma exacerbation compared to maintenance ICS/SABA reliever and represents an alternative for patients, particularly when severe exacerbation prevention is the primary treatment aim https://bit.ly/3mpHVKc

Background People living with dementia often face eating and drinking difficulties as life is ending. Family and friends find this emotionally challenging and professionals also struggle to provide information and support. The aim of this systematic review was to 1) explore the views of people with dementia and those involved in supporting eating and drinking for someone with dementia (paid and unpaid carers) at the end of life; and 2) explore views and experiences of artificial nutrition and hydration (ANH) for people with dementia. Methods A systematic search was conducted in Medline, CINAHL, Embase and PsycINFO, for English-language qualitative studies published between 2000 and 2019, and forward and backward citation tracking. Studies were synthesised using narrative synthesis and thematic analysis methods. Results 18 papers were included with six focussing on carers’ and 13 on professionals’ views. Professionals and carers reported on challenges associated with supporting nutrition and hydration and several strategies used to facilitate oral intake (i.e., modifying the environment and food provision). When ANH was considered, six main factors were identified as influencing decisions: 1) personal perceptions; 2) national context; 3) understanding of the natural dying process; 4) involvement of different parties (i.e., professionals in multidisciplinary teams, carers and the person living with dementia); 5) lack of information; and 6) prognosis. Discussion Decisions around eating and drinking and the introduction of ANH require clear and respectful communication among all involved (including those living with dementia), as their personal/professional experiences, perceptions and knowledge impact on their behaviours and emotions.