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AimTo describe the nature and causes of reported patient safety incidents relating to care in the community for children dependent on long-term ventilation with the further aim of improving safety.MethodsWe undertook an analysis of patient safety incident data relating to long-term ventilation in the community using incident reports from England and Wales’ National Reporting and Learning System occurring between January 2013 and December 2017. Manual screening by two authors identified 220 incidents which met the inclusion criteria. The free text for each report was descriptively analysed to identify the problems in the delivery of care, the contributory factors and the patient outcome.ResultsCommon problems in the delivery of care included issues with faulty equipment and the availability of equipment, and concerns around staff competency. There was a clearly stated harm to the child in 89 incidents (40%). Contributory factors included staff shortages, out of hours care, and issues with packaging and instructions for equipment.ConclusionsThis study identifies a range of problems relating to long-term ventilation in the community, some of which raise serious safety concerns. The provision of services to support children on long-term ventilation and their families needs to improve. Priorities include training of staff, maintenance and availability of equipment, support for families and coordination of care.

QuestionThe aim was to systematically collate and synthesise existing, publicly available patient-reported outcome measure (PROM) information suitable for quality of life (QOL)/well-being measurement in mental health economic evaluations, with specific focus on their applicability in multisectoral, multinational, multiperson economic evaluations and to develop an electronic PROM compendium with meta-data.Study selection and analysisA systematic literature search for non-disease-pecific PROMs and their versions suitable for the measurement of QOL/well-being or recovery was conducted from 2008 to February 2020. Six criteria were applied to judge their suitability in multisectoral, multinational, multiperson economic evaluations: (i) availability of separate adult and child/adolescent versions, (ii) availability of a proxy-completion option, (iii) assessing outcomes beyond health, (iv) availability of translations (≥2 language versions), (v) availability of a preference-based valuation, (vi) availability of value sets in more than one country.FindingsThe final ProgrammE in Costing, resource use measurement and outcome valuation for Use in multisectoral National and International health economic evaluAtions (PECUNIA) PROM-MH Compendium includes 204 unique scales, out of which 88 are individual instruments, while the remaining 116 scales belong to 46 PROM families with more than one distinctive version. Out of the total 134 individual PROMs/PROM families, 72% have at least two language versions, 8% measure broader well-being beyond health-related QOL, 11% have preference-based valuation, with multiple country sets available for 60% of these. None of the identified PROMs met all six proposed criteria.ConclusionsThe PECUNIA PROM-MH Compendium provides a unique overview of the relevant PROMs and their linked meta-data, and should be a helpful tool when choosing a suitable instrument for future mental health economic evaluations.

RationalePulmonary tuberculosis (PTB) can cause post-TB lung disease (PTLD) associated with respiratory symptoms, spirometric and radiological abnormalities. Understanding of the predictors and natural history of PTLD is limited.ObjectivesTo describe the symptoms and lung function of Malawian adults up to 3 years following PTB-treatment completion, and to determine the evolution of PTLD over this period.MethodsAdults successfully completing PTB treatment in Blantyre, Malawi were followed up for 3 years and assessed using questionnaires, post-bronchodilator spirometry, 6 min walk tests, chest X-ray and high-resolution CT. Predictors of lung function at 3 years were identified by mixed effects regression modelling.Measurement and main resultsWe recruited 405 participants of whom 301 completed 3 years follow-up (mean (SD) age 35 years (10.2); 66.6% males; 60.4% HIV-positive). At 3 years, 59/301 (19.6%) reported respiratory symptoms and 76/272 (27.9%) had abnormal spirometry. The proportions with low FVC fell from 57/285 (20.0%) at TB treatment completion to 33/272 (12.1%), while obstruction increased from and 41/285 (14.4%) to 43/272 (15.8%) at 3 years. Absolute FEV1and FVC increased by mean 0.03 L and 0.1 L over this period, but FEV1decline of more than 0.1 L was seen in 73/246 (29.7%). Higher spirometry values at 3 years were associated with higher body mass index and HIV coinfection at TB-treatment completion.ConclusionSpirometric measures improved over the 3 years following treatment, mostly in the first year. However, a third of PTB survivors experienced ongoing respiratory symptoms and abnormal spirometry (with accelerated FEV1decline). Effective interventions are needed to improve the care of this group of patients.

Vaccination is a life-saving endeavour, yet risk and uncertainty are unavoidable in science and medicine. Vaccination remains contentious in the public mind, and vaccine hesitancy is a serious public health issue. This has recently been reignited in the discussion over potential side effects of COVID-19 vaccines, and the decision by several countries to suspend measures such as the AstraZeneca vaccine. In these instances, the precautionary principle has often been invoked as a rationale, yet such heuristics do not adequately weigh potential harms against real benefits. How we analyse, communicate and react to potential harms is absolutely paramount to ensure the best decisions and outcomes for societal health, and maintaining public confidence. While balancing benefits and risks is an essential undertaking, it cannot be achieved without due consideration of several other pertinent factors, especially in the context of vaccination, where misguided or exaggerated fears have in the past imperilled public health. While well meaning, over reactions to potential hazards of vaccination and other health interventions can have unintended consequences, and cause lingering damage to public trust. In this analysis, we explore the challenges of assessing risk and benefit, and the limitations of the precautionary principle in these endeavours. When risk is unclear, cautious vigilance might be a more pragmatic and useful policy than reactionary suspensions.

ObjectiveTo optimise dementia prevention strategies, we must understand the complex relationships between lifestyle behaviours, frailty and genetics.MethodsWe explored relationships between frailty index, healthy lifestyle and polygenic risk scores (all assessed at study entry) and incident all-cause dementia as recorded on hospital admission records and death register data.ResultsThe analytical sample had a mean age of 64.1 years at baseline (SD=2.9) and 53% were women. Incident dementia was detected in 1762 participants (median follow-up time=8.0 years). High frailty was associated with increased dementia risk independently of genetic risk (HR 3.68, 95% CI 3.11 to 4.35). Frailty mediated 44% of the relationship between healthy lifestyle behaviours and dementia risk (indirect effect HR 0.95, 95% CI 0.95 to 0.96). Participants at high genetic risk and with high frailty had 5.8 times greater risk of incident dementia compared with those at low genetic risk and with low frailty (HR 5.81, 95% CI 4.01 to 8.42). Higher genetic risk was most influential in those with low frailty (HR 1.31, 95% CI 1.22 to 1.40) but not influential in those with high frailty (HR 1.09, 95% CI 0.92 to 1.28).ConclusionFrailty is strongly associated with dementia risk and affects the risk attributable to genetic factors. Frailty should be considered an important modifiable risk factor for dementia and a target for dementia prevention strategies, even among people at high genetic risk.

ObjectivesTo evaluate systemic lupus erythematosus (SLE) flares following hydroxychloroquine (HCQ) reduction or discontinuation versus HCQ maintenance.MethodsWe analysed prospective data from the Systemic Lupus International Collaborating Clinics (SLICC) cohort, enrolled from 33 sites within 15 months of SLE diagnosis and followed annually (1999–2019). We evaluated person-time contributed while on the initial HCQ dose (‘maintenance’), comparing this with person-time contributed after a first dose reduction, and after a first HCQ discontinuation. We estimated time to first flare, defined as either subsequent need for therapy augmentation, increase of ≥4 points in the SLE Disease Activity Index-2000, or hospitalisation for SLE. We estimated adjusted HRs (aHRs) with 95% CIs associated with reducing/discontinuing HCQ (vs maintenance). We also conducted separate multivariable hazard regressions in each HCQ subcohort to identify factors associated with flare.ResultsWe studied 1460 (90% female) patients initiating HCQ. aHRs for first SLE flare were 1.20 (95% CI 1.04 to 1.38) and 1.56 (95% CI 1.31 to 1.86) for the HCQ reduction and discontinuation groups, respectively, versus HCQ maintenance. Patients with low educational level were at particular risk of flaring after HCQ discontinuation (aHR 1.43, 95% CI 1.09 to 1.87). Prednisone use at time-zero was associated with over 1.5-fold increase in flare risk in all HCQ subcohorts.ConclusionsSLE flare risk was higher after HCQ taper/discontinuation versus HCQ maintenance. Decisions to maintain, reduce or stop HCQ may affect specific subgroups differently, including those on prednisone and/or with low education. Further study of special groups (eg, seniors) may be helpful.

ObjectivesTo evaluate the joint (combined) association of excess adiposity and genetic predisposition with the risk of incident female gout, and compare to their male counterparts; and determine the proportion attributable to body mass index (BMI) only, genetic risk score (GRS) only, and to their interaction.MethodsWe prospectively investigated potential gene-BMI interactions in 18 244 women from the Nurses’ Health Study and compared with 10 888 men from the Health Professionals Follow-Up Study. GRS for hyperuricaemia was derived from 114 common urate-associated single nucleotide polymorphisms.ResultsMultivariable relative risk (RR) for female gout was 1.49 (95% CI 1.42 to 1.56) per 5 kg/m2increment of BMI and 1.43 (1.35 to 1.52) per SD increment in the GRS. For their joint association of BMI and GRS, RR was 2.18 (2.03 to 2.36), more than the sum of each individual factor, indicating significant interaction on an additive scale (p for interaction ConclusionsWhile excess adiposity and genetic predisposition both are strongly associated with a higher risk of gout, the excess risk of both combined was higher than the sum of each, particularly among women.

ObjectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.MethodsSurvey of primary trial reports, published 2014–2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.ResultsAmong 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (pDiscussionNot obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public’s trust in research.

Background/AimsTo provide longer-term data on efficacy, safety, immunogenicity and pharmacokinetics (PK) of ranibizumab biosimilar SB11 compared with the reference ranibizumab (RBZ) in patients with neovascular age-related macular degeneration (nAMD).MethodsSetting: Multicentre.Design: Randomised, double-masked, parallel-group, phase III equivalence study.Patient population: ≥50 years old participants with nAMD (n=705), one ‘study eye’. Intervention: 1:1 randomisation to monthly intravitreal injection of 0.5 mg SB11 or RBZ.Main outcome measures: Visual efficacy endpoints, safety, immunogenicity and PK up to 52 weeks.ResultsBaseline and disease characteristics were comparable between treatment groups. Of 705 randomised participants (SB11: n=351; RBZ: n=354), 634 participants (89.9%; SB11: n=307; RBZ: n=327) completed the study until week 52. Previously reported equivalence in primary efficacy remained stable up to week 52 and were comparable between SB11 and RBZ. The adjusted treatment difference between SB11 and RBZ in full analysis set at week 52 of change from baseline in best-corrected visual acuity was −0.6 letters (90% CI −2.1 to 0.9) and of change from baseline in central subfield thickness was −14.9 µm (95% CI –25.3 to –4.5). The incidence of ocular treatment-emergent adverse events (TEAEs) (SB11: 32.0% vs RBZ: 29.7%) and serious ocular TEAE (SB11: 2.9% vs RBZ: 2.3%) appeared comparable between treatment groups, and no new safety concerns were observed. The PK and immunogenicity profiles were comparable, with a 4.2% and 5.5% cumulative incidence of antidrug antibodies up to week 52 for SB11 and RBZ, respectively.ConclusionsLonger-term results of this study further support the biosimilarity established between SB11 and RBZ.

IntroductionThe work of carrying water falls mainly on women and children, particularly in sub-Saharan Africa and rural areas. While concerns have been raised, how water carriage is associated with health of the water carrier is not clear. The aim of this review is to summarise evidence on whether, and how, water carriage is associated with the water carrier’s health.MethodsA systematic review of literature was conducted, searching Embase; Medline; Web of Science Social Sciences Citation Index; Web of Science Arts and Humanities Citation Index; International Initiative for Impact Evaluation website; WHO Virtual Health Sciences Library and WHO African index medicus, from inception to 8 November 2017.ResultsForty-two studies were included. Their ability to demonstrate cause and effect relationships was limited by study design and fair or poor methodological quality. Overall, the studies suggest that water carriage is associated with negative aspects of the water carriers’ health. There is moderate quantitative and strong qualitative evidence that water carriage is associated with pain, fatigue, perinatal health problems and violence against vulnerable people, and inconclusive evidence of an association with stress or self-reported mental health and general health status.ConclusionIn many circumstances, water carriage is a potential barrier to Sustainable Development Goal (SDG) 6 target ‘universal and equitable access to safe and affordable drinking water for all’ and SDG 3 ‘ensure healthy lives and promote well-being for all at all ages’. Efforts should focus on providing water on premises, and where this is not possible, providing water close to home and reducing risk of gender-based violence.

BackgroundThe number of adults across the globe with significant depressive symptoms has grown substantially during the COVID-19 pandemic. The extant literature supports exercise as a potent behaviour that can significantly reduce depressive symptoms in clinical and non-clinical populations.ObjectiveUsing a suite of mobile applications, at-home exercise, including high intensity interval training (HIIT) and/or yoga, was completed to reduce depressive symptoms in the general population in the early months of the pandemic.MethodsA 6-week, parallel, multiarm, pragmatic randomised controlled trial was completed with four groups: (1) HIIT, (2) Yoga, (3) HIIT+yoga, and (4) waitlist control (WLC). Low active, English-speaking, non-retired Canadians aged 18–64 years were included. Depressive symptoms were measured at baseline and weekly following randomisation.ResultsA total of 334 participants were randomised to one of four groups. No differences in depressive symptoms were evident at baseline. The results of latent growth modelling showed significant treatment effects in depressive symptoms for each active group compared with the WLC, with small effect sizes (ESs) in the community-based sample of participants. Treatment groups were not significantly different from each other. Effect sizes were very large (eg, week 6 ES range=−2.34 to −2.52) when restricting the analysis only to participants with high depressive symptoms at baseline.ConclusionsAt-home exercise is a potent behaviour to improve mental health in adults during the pandemic, especially in those with increased levels of depressive symptoms. Promotion of at-home exercise may be a global public health target with important personal, social and economic implications as the world emerges scathed by the pandemic.Trial registration numberNCT04400279.

BackgroundChildhood obesity is a major public health concern. This study evaluated the independent and joint associations of family-level income, neighbourhood-level income and neighbourhood deprivation, in relation to child obesity.MethodsA cross-sectional study was conducted in children ≤12 years of age from TARGet Kids! primary care network (Greater Toronto Area, 2013–2019). Parent-reported family income was compared with median neighbourhood income and neighbourhood deprivation measured using the Ontario Marginalization Index. Children’s height and weight were measured and body mass index (BMI) z-scores (zBMI) were calculated. ORs and 95% CIs were estimated for the three exposure variables separately using multilevel multinomial logistic regression models with zBMI categories as the outcome, adjusting in model 1 for age, sex, ethnicity and number of family members and in model 2 adding family income. A joint measure was derived combining income and deprivation measures.ResultsA total of 5962 children were included. Low family income (Q1 vs Q5: OR=4.69, 95% CI 2.65 to 8.29), low neighbourhood income (Q1 vs Q5: OR=2.18, 95% CI 1.33 to 3.58) and high neighbourhood deprivation (Q1 vs Q5: OR=2.45, 95% CI 1.52 to 3.95) were each associated with increased OR of child obesity. However, after adjustment for family income, the association for both neighbourhood income (OR=1.39, 95% CI 0.82 to 2.34) and deprivation (OR=1.56, 95% CI 0.94 to 2.58) and obesity was attenuated. Children from low-income families living in low-income or high deprivation neighbourhoods had higher OR of obesity.ConclusionChild obesity was independently associated with low family-level income and a joint measure suggests that neighbourhood also matters. Socioeconomic inequalities at both individual and neighbourhood levels should be addressed in childhood obesity interventions.

The medical community has recently acknowledged physician stress as a leading issue for individual wellness and healthcare system functioning. Unprecedented levels of stress contribute to physician burnout, leaves of absence and early retirement. Although recommendations have been made, we continue to struggle with addressing stress. One challenge is a lack of a shared definition for what we mean by ‘stress’, which is a complex and idiosyncratic phenomenon that may be examined from a myriad of angles. As such, research on stress has traditionally taken a reductionist approach, parsing out one aspect to investigate, such as stress physiology. In the medical domain, we have traditionally underappreciated other dimensions of stress, including emotion and the role of the environmental and sociocultural context in which providers are embedded. Taking a complementary, holistic approach to stress and focusing on the composite, subjective individual experience may provide a deeper understanding of the phenomenon and help to illuminate paths towards wellness. In this review article, we first examine contributions from unidimensional approaches to stress, and then outline a complementary, integrated approach. We describe how complex phenomena have been tackled in other domains and discuss how holistic theory and the humanities may help in studying and addressing physician stress, with the ultimate goal of improving physician well-being and consequently patient care.

ObjectiveThe effect of moderate excess alcohol consumption is widely debated and has not been well defined in dilated cardiomyopathy (DCM). There is need for a greater evidence base to help advise patients. We sought to evaluate the effect of moderate excess alcohol consumption on cardiovascular structure, function and outcomes in DCM.MethodsProspective longitudinal observational cohort study. Patients with DCM (n=604) were evaluated for a history of moderate excess alcohol consumption (UK government guidelines; >14 units/week for women, >21 units/week for men) at cohort enrolment, had cardiovascular magnetic resonance and were followed up for the composite endpoint of cardiovascular death, heart failure and arrhythmic events. Patients meeting criteria for alcoholic cardiomyopathy were not recruited.ResultsDCM patients with a history of moderate excess alcohol consumption (n=98, 16%) had lower biventricular function and increased chamber dilatation of the left ventricle, right ventricle and left atrium, as well as increased left ventricular hypertrophy compared with patients without moderate alcohol consumption. They were more likely to be male (alcohol excess group: n=92, 94% vs n=306, 61%, p=ConclusionDCM patients with moderate excess alcohol consumption have adverse cardiac structure and function at presentation, but this is largely due to biological sex. Alcohol may contribute to sex-specific phenotypic differences in DCM. These findings help to inform lifestyle discussions for patients with DCM.

ObjectiveLittle is known on optimal screening population for detecting new atrial fibrillation (AF) in the community. We describe characteristics and estimate cost-effectiveness for a single timepoint electrocardiographic screening.MethodsWe performed a 12-lead ECG in the German population-based Gutenberg Health Study between 2007 and 2012 (n=15 010), mean age 55±11 years, 51% men and collected more than 120 clinical and biomarker variables, including N-terminal pro B-type natriuretic peptide (Nt-proBNP), risk factors, disease symptoms and echocardiographic variables.ResultsOf 15 010 individuals, 466 (3.1%) had AF. New AF was found in 32 individuals, 0.2% of the total sample, 0.5% of individuals aged 65–74 years and predominantly men (86%). The classical risk factor burden was high in individuals with new AF. The median estimated stroke risk was 2.2%/year, while risk of developing heart failure was 21% over 10 years. In the 65–74 year age group, the cost per quality-adjusted life-year gained resulting from a single timepoint screening was €30 361. In simulations, the costs were highly sensitive to AF detection rates, proportion of treatment and type of oral anticoagulant. Prescreening by Nt-proBNP measurements was not cost-effective in the current setting.ConclusionsIn our middle-aged population cohort, we identified 0.2% new AF by single timepoint screening. There was a significant estimated risk of stroke and heart failure in these individuals. Cost-effectiveness for screening may be reached in individuals aged 65 years and older. The simple age cut-off is not improved by using Nt-proBNP as a biomarker to guide a screening programme.

ObjectivesTo report COVID-19 illness pattern, symptom duration and time loss in UK elite athletes.MethodsObservational, clinical and database review of athletes with symptomatic COVID-19 illness managed within the UK Sports Institutes. Athletes were classified as confirmed (positive SARS-CoV-2 PCR or antibody tests) or probable (consistent clinical features) COVID-19. Clinical presentation was characterised by the predominant symptom focus (eg, upper or lower respiratory illness). Time loss was defined as days unavailable for full sport participation and comparison was made with a 2016–2019 respiratory illness dataset from the same surveillance system.ResultsBetween 24 February 2020 and 18 January 2021, 147 athletes (25 Paralympic (17%)) with mean (SD) age 24.7 (5.2) years, 37% female, were diagnosed with COVID-19 (76 probable, 71 confirmed). Fatigue was the most prevalent symptom (57%), followed by dry cough (50%) and headache (46%). The median (IQR) symptom duration was 10 (6–17) days but 14% reported symptoms >28 days. Median time loss was 18 (12–30) days, with 27% not fully available >28 days from initial date of infection. This was greater than our historical non-COVID respiratory illness comparator; 6 days, 0–7 days (pConclusionsIn this cohort, COVID-19 largely resulted in a mild, self-limiting illness. The presence of lower respiratory tract features was associated with prolonged illness and a delayed return to sport.

ObjectiveTo evaluate if proton pump inhibitor (PPI) treatment reduces the risk of upper gastrointestinal bleeding (UGIB) in patients with atrial fibrillation (AF) treated with non-vitamin K antagonist oral anticoagulants (NOACs).DesignWe used a common protocol, common data model approach to conduct a cohort study including patients with AF initiated on a NOAC in Stockholm, Denmark and the Netherlands from April 2011 until July 2018. The outcome of interest was a UGIB diagnosed in a secondary care inpatient setting. We used an inverse probability weighted (IPW) Poisson regression to calculate incidence rate ratios (IRRs), contrasting PPI use to no PPI use periods.ResultsIn 164 290 NOAC users with AF, providing 272 570 years of follow-up and 39 938 years of PPI exposure, 806 patients suffered a UGIB. After IPW, PPI use was associated with lower UGIB rates (IRR: 0.75; 95% CI: 0.59 to 0.95). On an absolute scale, the protective effect was modest, and was found to be largest in high-risk patients, classified as age 75–84 years (number needed to treat for 1 year (NNTY): 787), age ≥85 years (NNTY: 667), HAS-BLED score ≥3 (NNTY: 378) or on concomitant antiplatelet therapy (NNTY: 373).ConclusionConcomitant treatment with a PPI in NOAC-treated patients with AF is associated with a reduced risk of severe UGIB. This indicates that PPI cotreatment can be considered, in particular among the elderly patients, patients with a HAS-BLED score ≥3, and/or in patients on concomitant antiplatelet therapy.

BackgroundThe BEVORDEX trial compared outcomes of eyes with diabetic macular oedema (DMO) randomised to receive either intravitreal dexamethasone (DEX-) implant or bevacizumab over 2 years. We assessed long-term efficacy and safety outcomes 5 years from enrolment.MethodsPatients received standard clinical care after they finished the study. Their files were reviewed for visual and anatomical outcomes, post-trial treatments and complications.ResultsThree-year and five-year data were available for 82% and 59% of eyes enrolled in the BEVORDEX study, respectively. Visual acuity gains at end of trial were generally lost by both treatment groups at 5 years but the macular thickness did not change from end of trial to 5 years. A similar proportion of eyes from each treatment group gained ≥10 letters at 5 years from enrolment in the BEVORDEX trial.Eyes that were initially randomised to the DEX-implant group had significantly fewer treatments but were more likely to develop proliferative diabetic retinopathy (PDR) over the 5-year period compared with eyes initially randomised to bevacizumab. The proportion of eyes that had cataract surgery by 5 years was similar between initial treatment groups.ConclusionsEyes in the BEVORDEX trial had similar 5-year rates of cataract surgery, however, more eyes converted to PDR in the group initially treated with DEX-implant. Eyes that were initially treated for 2 years with either intravitreal DEX-implant of bevacizumab followed by standard of care had similar visual and anatomical outcomes at 5 years.

Most jurisdictions require that a mental capacity assessment be conducted using a functional model whose definition includes several abilities. In England and Wales and in increasing number of countries, the law requires a person be able to understand, to retain, to use or weigh relevant information and to communicate one’s decision. But interpreting and applying broad and vague criteria, such as the ability ‘to use or weigh’ to a diverse range of presentations is challenging. By examining actual court judgements of capacity, we previously developed a descriptive typology of justifications (rationales) used in the application of the Mental Capacity Act (MCA) criteria. We here critically optimise this typology by showing how clear definitions—and thus boundaries—between the criteria can be achieved if the ‘understanding’ criterion is used narrowly and the multiple rationales that fall under the ability to ‘use or weigh’ are specifically enumerated in practice. Such a typology-aided practice, in theory, could make functional capacity assessments more transparent, accountable, reliable and valid. It may also help to create targeted supports for decision making by the vulnerable. We also discuss how the typology could evolve legally and scientifically, and how it lays the groundwork for clinical research on the abilities enumerated by the MCA.

ObjectiveDiuretics reduce congestion in patients with heart failure with preserved ejection fraction (HFpEF). However, comparison of clinical effects across diuretic classes or combinations of diuretics in patients with HFpEF are not well described. Therefore, we sought to conduct a scoping review to map trial data of diuretic efficacy and safety in patients with HFpEF.Review methods and resultsWe searched multiple bibliometric databases for published literature and ClinicalTrials.gov, and hand searched unpublished studies comparing different classes of diuretics to usual care or placebo in patients with HFpEF. We included randomised controlled trials or quasi-experimental studies. Two authors independently screened and extracted key data using a structured form. We identified 13 published studies on diuretics in HFpEF, with 1 evaluating thiazide use, 7 on mineralocorticoid receptor antagonists (MRAs) and 5 on sodium-glucose co-transporter 2 inhibitors (SGLT2i). There remain 17 ongoing trials evaluating loop diuretics (n=1), MRAs (n=5), SGLT2i (n=10) and a polydiuretic (n=1), including 2 well-powered trials of SGLT2i that will be completed in 2021.ConclusionsThe limited number of published trials evaluating different classes of diuretics in patients with HFpEF have been generally small and short term. Ongoing and emerging trials of single or combination diuretics with greater power will be useful to better define their safety and efficacy.Scoping review registrationdoi:10.18131/g3-dejv-tm77.

ObjectiveUnprecedented SARS-CoV-2 infections in farmed minks raised immediate concerns regarding transmission to humans and initiated intensive environmental investigations to assess occupational and environmental exposure.MethodsAir sampling was performed at infected Dutch mink farms, at farm premises and at nearby residential sites. A range of other environmental samples were collected from minks’ housing units, including bedding materials. SARS-CoV-2 RNA was analysed in all samples by quantitative PCR.ResultsInside the farms, considerable levels of SARS-CoV-2 RNA were found in airborne dust, especially in personal inhalable dust samples (approximately 1000–10 000 copies/m3). Most of the settling dust samples tested positive for SARS-CoV-2 RNA (82%, 75 of 92). SARS-CoV-2 RNA was not detected in outdoor air samples, except for those collected near the entrance of the most recently infected farm. Many samples of minks’ housing units and surfaces contained SARS-CoV-2 RNA.ConclusionsInfected mink farms can be highly contaminated with SARS-CoV-2 RNA. This warns of occupational exposure, which was substantiated by considerable SARS-CoV-2 RNA concentrations in personal air samples. Dispersion of SARS-CoV-2 to outdoor air was found to be limited and SARS-CoV-2 RNA was not detected in air samples collected beyond farm premises, implying a negligible risk of environmental exposure to nearby communities. Our occupational and environmental risk assessment is in line with whole genome sequencing analyses showing mink-to-human transmission among farm workers, but no indications of direct zoonotic transmission events to nearby communities.

In March 2021, the Spanish Congress approved the law regulating euthanasia, that regulates both euthanasia and physician-assisted suicide (PAS). In this article, we analyse the Spanish law regulating euthanasia and PAS, comparing it with the rest of the European laws on euthanasia and PAS (Netherlands, Belgium and Luxembourg). Identified strengths of the Spanish law, with respect to other norms, are that it is a law with many safeguards, which broadly recognises professionals’ right to conscientious objection and the specification that it makes on the prior comprehensive care of the patient, including the approach to care dependency. Regarding its shortcomings, the law does not differentiate well between euthanasia and PAS; it barely assigns a role to the healthcare team as a whole (similar to other regulations); it does not clarify the functions of the different professionals involved; it does not detail the specific composition and duration of theevaluation commission; it has not been accompanied by a prior or simultaneous regulation of palliative care; and, lastly, the period of time to implement the law is too short.

Digital media has a global reach that includes increasingly marginalised and vulnerable communities. Engaging, empowering media paired with key health messaging can provide education in more effective ways, build trust and bring communities together. An HIV testing and study recruitment film was co-created with a multidisciplinary team of HIV/sexual health physicians, medical and social science researchers from Bali, Jakarta and London, as well as members of the community and commercial film and media creatives. This short film provides a novel and innovative approach to recruit to a social science study and encourage HIV testing among men who have sex with men in Indonesia. This study aims to inform a digital HIV risk reduction tool for a community affected by increasing marginalisation and a fast-growing HIV epidemic.

ObjectivesAn increasing number of US states have required a tax on electronic nicotine delivery systems (ENDS) in the past few years. This study evaluated the effect of statewide vaping product excise tax policy on ENDS use among young adults.MethodsWe used the two recent waves (2014–2019) of the Tobacco Use Supplement to the Current Population Survey. A total of 17 896 US young adults were analysed. Difference-in-differences approach along with weighted multilevel logistic regressions was used to evaluate the association of vaping product excise tax policy adoption with current ENDS use, accounting for the clustering of respondents within the same states.ResultsThere was an increase in current ENDS use prevalence from 2014–2015 (3.4%) to 2018–2019 (5.4%). Respondents living in states with vaping product excise tax policy showed significantly lower increase in ENDS use prevalence during the study period (interaction between within-state changes and between-state differences: adjusted OR (AOR)=0.57, 95% CI=0.35 to 0.91), controlling for other state-level policies and sociodemographic characteristics. Additional stratified analysis with state-fixed effects by vaping product excise tax policy implementation status showed consistent findings.ConclusionsOur findings suggest that adopting a vaping product excise tax policy may help reduce ENDS use and suppress the increase of ENDS use prevalence among young adults. Considering that there are still a number of US states that have not implemented vaping product excise tax policy, wider adoption of such policy across the nation would likely help mitigate ENDS use prevalence.

BackgroundType 2 diabetes mellitus (T2DM) has been associated with infectious diseases; however, whether T2DM is associated with bacterial-resistant infections has not been thoroughly studied. We ascertained whether people with T2DM were more likely to experience resistant infections in comparison to T2DM-free individuals.MethodsSystematic review and random-effects meta-analysis. The search was conducted in Medline, Embase and Global Health. We selected observational studies in which the outcome was resistant infections (any site), and the exposure was T2DM. We studied adult subjects who could have been selected from population-based or hospital-based studies. I2 was the metric of heterogeneity. We used the Newcastle-Ottawa risk of bias scale.ResultsThe search retrieved 3370 reports, 97 were studied in detail and 61 (449 247 subjects) were selected. Studies were mostly cross-sectional or case–control; several infection sites were studied, but mostly urinary tract and respiratory infections. The random-effects meta-analysis revealed that people with T2DM were twofold more likely to have urinary tract (OR=2.42; 95% CI 1.83 to 3.20; I2 19.1%) or respiratory (OR=2.35; 95% CI 1.49 to 3.69; I2 58.1%) resistant infections. Although evidence for other infection sites was heterogeneous, they consistently suggested that T2DM was associated with resistant infections.ConclusionsCompelling evidence suggests that people with T2DM are more likely to experience antibiotic-resistant urinary tract and respiratory infections. The evidence for other infection sites was less conclusive but pointed to the same overall conclusion. These results could guide empirical treatment for patients with T2DM and infections.

ObjectivesIn an attempt to understand the demand and main drivers of telemedicine abortion, we analysed the requests that Women on Web (WoW), an online telemedicine abortion service operating worldwide, received from France throughout 2020.MethodsWe conducted a parallel, convergent, mixed-methods study among 809 consultations received from France at WoW between 1 January and 31 December 2020. We performed a cross-sectional study of data obtained from the WoW consultation survey and a manifest content analysis of anonymised email correspondence of 140 women consulting with the WoW helpdesk from France.FindingsWe found that women encounter macro-level, individual-level and provider-level constraints while trying to access abortion in France. The preferences and needs over secrecy (n=356, 46.2%), privacy (n=295, 38.3%) and comfort (n=269, 34.9%) are among the most frequent reasons for women from France to choose telemedicine abortion through WoW. The COVID-19 pandemic seems to be an important driver for resorting to telemedicine (n=236, 30.6%). The lockdowns had a significant impact on the number of consultations received at WoW from France, increasing from 60 in March to 128 in April during the first lockdown and from 54 in October to 80 in November during the second lockdown.ConclusionsThe demand for at-home medical abortion via teleconsultation increased in France during the lockdowns. However, drivers of telemedicine abortion are multidimensional and go beyond the conditions unique to the pandemic.

ObjectiveTo evaluate trends in respiratory care practices and bronchopulmonary dysplasia (BPD) among very preterm infants born in Spain between 2010 and 2019.Study designThis was a retrospective cohort study of data obtained from a national population-based database (SEN1500 network). Changes in respiratory care and BPD-free survival of infants with gestational age (GA) of 230–316 weeks and ResultsA total of 17 952 infants were included. In the second period, infants were less frequently intubated in the delivery room and during neonatal intensive care unit stay. This corresponded with an increase in use of non-invasive ventilation techniques. There were no significant differences between the periods in BPD-free survival or survival without moderate-to-severe BPD. After adjusting for covariates, the RR for the change per year was significant for the following variables: never intubated (RR 1.03, 95% CI 1.02 to 1.04); intubation in the delivery room (RR 0.98, 95% CI 0.97 to 0.99); use of nasal intermittent positive pressure ventilation (RR 1.08, 95% CI 1.05 to 1.11); and BPD-free survival (only in the group with the lowest GA; RR 0.98, 95% CI 0.97 to 0.99).ConclusionOur findings reveal significant changes in respiratory care practices between 2009 and 2019. Despite an increase in use of non-invasive respiratory strategies, BPD-free survival did not improve and even worsened in the group with the lowest GA (230–256).

ObjectivesRecent evidence suggests that occupational physical activity (OPA) is associated with adverse cardiovascular health, whereas leisure time physical activity is protective. This study explored explanatory physiological mechanisms.MethodsNineteen males (68% white, age=46.6±7.9 years, body mass index=27.9±5.1 kg/m2) with high self-reported OPA wore activity (ActiGraph and activPAL) and heart rate (HR) monitors for 7 days and an ambulatory blood pressure (BP) monitor on one workday and one non-workday. Mixed effects models compared cardiovascular variables (24-hour, nocturnal, waking and non-work time HR and BP) and nocturnal HR variability (HRV) on workdays versus non-workdays. Additional models examined associations of daily activity (steps, light physical activity (LPA) and moderate-to-vigorous physical activity (MVPA)) with cardiovascular variables. Workday by daily activity interactions were examined.Results24-hour and waking HR and diastolic BP as well as non-work diastolic BP were significantly higher on workdays versus non-workdays (p0.05 for all). Low-frequency and high-frequency power indices of nocturnal HRV were lower on workdays (pConclusionsCardiovascular load was higher on workdays versus non-workdays with no compensatory hypotensive response following workdays. Daily MVPA may differentially affect ambulatory cardiovascular load and nocturnal HRV on workdays versus non-workdays, supporting the physical activity health paradox hypothesis.

BackgroundMalnutrition is a global emergency, creating an overlapping burden on individual, public and economic health. The double burden of malnutrition affects approximately 2.3 billion adults worldwide. Following 3 years of capacity building work in Kolkata, with assistance of local volunteers and organisations, we established an empowering nutrition education model in the form of a ‘mobile teaching kitchen (MTK)’ with the aim of creating culinary health educators from lay slum-dwelling women.AimsTo evaluate the piloting of a novel MTK nutrition education platform and its effects on the participants, alongside data collection feasibility.MethodsOver 6 months, marginalised (RG Kar and Chetla slums) women underwent nutrition training using the MTK supported by dietitians, doctors and volunteers. Preintervention and postintervention assessments of knowledge, attitudes and practices (KAP), as well as anthropometric and clinical nutritional status of both the women and their children were recorded. The education was delivered by a ‘See One, Do One, Teach One’ approach with a final assessment of teaching delivery performed in the final session.ResultsTwelve women were trained in total, six from each slum. Statistically significant improvements were noted in sections of KAP, with improvements in nutrition knowledge (+4.8) and practices (+0.8). In addition, statistically significant positive changes were seen in ‘understanding of healthy nutrition for their children’ (p=0.02), ‘sources of protein rich food’ (p=0.02) and ‘not skipping meals if a child is ill’ (p≤0.001).ConclusionThe MTK as a public health intervention managed to educate, empower and upskill two groups of lay marginalised women into MTK Champions from the urban slums of Kolkata, India. Improvements in their nutrition KAP demonstrate just some of the effects of this programme. By the provision of healthy meals and nutritional messages, the MTK Champions are key drivers nudging improvements in nutrition and health related awareness with a ripple effect across the communities that they serve. There is potential to upscale and adapt this programme to other settings, or developing into a microenterprise model, that can help future MTK Champions earn a stable income.

Tuberculosis (TB) may affect the nervous system in many ways. We describe an immunocompetent teenage girl with lymph node TB who had first presented with bilateral optic neuritis. Detailed history identified features inconsistent with immune-mediated optic neuritis. Several unusual features prompted further investigation, including transient visual obscurations without raised intracranial pressure, prominent disc swelling and absence of laboratory findings to support an immune-mediated cause. Whole body PET/MR imaging identified widespread mediastinal and supraclavicular lymphadenopathy. Despite no known TB contacts, a negative interferon gamma release assay and a normal chest X-ray, a targeted lymph node biopsy confirmed TB.

BackgroundApproximately 1/3 of patients with epilepsy have drug-resistant epilepsy (DRE) and require surgical interventions. This meta-analysis aimed to review the effectiveness of MRI-guided laser interstitial thermal therapy (MRgLITT) in DRE.MethodsThe Population, Intervention, Comparator and Outcome approach and Preferred Reporting Items for Systematic Reviews and Meta-Analyses were followed. PubMed, MEDLINE and EMBASE databases were systematically searched for English language publications from 2012 to Nov 2020. Data on the prevalence outcome using the Engel Epilepsy Surgery Outcome Scale (Class I–IV), and postoperative complications were analysed with 95% CIs.ResultsTwenty-eight studies that included a total of 559 patients with DRE were identified. The overall prevalence of Engel class I outcome was 56% (95% CI 0.52% to 0.60%). Hypothalamic hamartomas (HH) patients had the highest seizure freedom rate of 67% (95% CI 0.57% to 0.76%) and outcome was overall comparable between mesial temporal lobe epilepsy (mTLE) (56%, 95% CI 0.50% to 0.61%) and extratemporal epilepsy (50% 95% CI 0.40% to 0.59%). The mTLE cases with mesial temporal sclerosis had better outcome vs non-lesional cases of mTLE. The prevalence of postoperative adverse events was 19% (95% CI 0.14% to 0.25%) and the most common adverse event was visual field deficits. The reoperation rate was 9% (95% CI 0.05% to 0.14%), which included repeat ablation and open resection.ConclusionMRgLITT is an effective and safe intervention for DRE with different disease aetiologies. The seizure freedom outcome is overall comparable in between extratemporal and temporal lobe epilepsy; and highest with HH.Trail registration numberThe study protocol was registered with the National Institute for Health Research (CRD42019126365), which serves as a prospective register of systematic reviews. It is an international database of prospectively registered systematic reviews with a focus on health-related outcomes. Details about the protocol can be found at https://wwwcrdyorkacuk/PROSPERO/.

ObjectiveTo compare event and incidence rates of herpes zoster (HZ), also known as shingles, in patients with rheumatoid arthritis under treatment with conventional synthetic (cs), targeted synthetic (ts) or biologic (b) disease-modifying antirheumatic drugs (DMARDs).MethodsPatients were prospectively enrolled from 2007 until October 2020. Reported HZ events were assigned to ongoing treatments or those terminated within 1 month prior to the HZ event. Exposure-adjusted event rates (EAERs) of HZ were calculated per 1000 patient years (py) and adjusted HRs with 95% CIs computed. Inverse probability weights (IPW) were used to adjust for confounding by indication.ResultsData of 13 991 patients (62 958 py) were analysed, with 559 HZ events reported in 533 patients. The EAER of HZ was highest for tsDMARDs (21.5, 95% CI 16.4 to 27.9), followed by B cell targeted therapy (10.3, 95% CI 8.0 to 13.0), monoclonal antitumour necrosis factor (anti-TNF) antibodies (9.3, 95% CI 7.7 to 11.2), interleukin 6 inhibitors (8.8, 95% CI 6.9 to 11.0), soluble TNF receptor fusion protein (8.6, 95% CI 6.8 to 10.8), T cell costimulation modulator (8.4, 95% CI 5.9 to 11.8) and csDMARDs (7.1, 95% CI 6.0 to 8.3). Adjusted for age, sex and glucocorticoids and weighted with IPW, tsDMARDs (HR 3.66, 95% CI 2.38 to 5.63), monoclonal anti-TNF antibodies (HR 1.63, 95% CI 1.17 to 2.28) and B cell targeted therapy (HR 1.57, 95% CI 1.03 to 2.40) showed a significantly higher risk compared with csDMARDs.ConclusionOur results provide evidence for a 3.6-fold increased risk of HZ associated with tsDMARDs and an increased risk of HZ under bDMARDs compared with csDMARDs.

BackgroundIndia’s tobacco-free film and TV rules were implemented from 2012. To assess the effect of the rules, we studied tobacco depictions in top-grossing Bollywood films released between 2006 and 2017 and rule compliance after 2012.MethodsTobacco incidents and brand appearances were coded in 240 top-grossing Bollywood films (2006–2017) using the Breathe California method. Trends in number of tobacco incidents per film per year were studied before and after implementation of the rules using Poisson regression analysis. Compliance with rules over the years was studied using Pearson product-moment correlations.ResultsForty-five films were U-rated (all ages), 162 were UA-rated (below age 12 years must be adult-accompanied), and 33 were A-rated (age 18+ years only). Before implementation of the rules, the number of tobacco incidents per film was increasing by a factor of 1.1/year (95% CI 1.0 to 1.2, p=0.002). However, beginning year 2013, the number of incidents per film started falling significantly by a factor of 0.7/year (95% CI 0.6 to 0.9; p=0.012) compared with the previous increasing trend. The percentage of youth-rated (U and UA) films with any tobacco incidents also declined from a peak of 76% in 2012 to 35% in 2017. The percentage of films complying with the rules (audio-visual disclaimers, health spots, static warnings) did not change significantly from 2012 to 2017.ConclusionIndia’s 2012 rules were followed by a reduction in tobacco depictions in Bollywood films. Enhanced monitoring of compliance is needed to ensure the continued effectiveness of the rules.

Informing families about the impending or actual death of their relatives is one of the most challenging and complex tasks a physician may face. The following article describes goal setting and provides five roles/recommendations for conducting the encounter with patient families regarding the imminent or actual death of their relatives. Importantly, the encounter should be family-centred, and the physician should be highly attentive to family needs. The following roles should be applied based on family needs and should not be sequential as numbered. The first and basic role is to inform the family at the earliest possible time and as often as possible. The second goal of the physician is to convey to the family that their relative received the needed therapy during his hospitalisation or in the community. The third goal of the physician is to help the family reach acceptance of the death of their relative and leave the hospital having moved beyond anger and bargaining. The fourth goal of the physician during the encounters is to reduce or alleviate guilt by stating that nothing could have changed the course of the disease and that all efforts were made to save the patient. The fifth role of the physician is to try and help the family as a single entity and maintain their unity during this stressful situation. Following these roles/methods will help families in the stressful situation and will create the difference between anger and understanding, rage and compassion, and loss and acceptance.

Background/AimsLong COVID is characterised by a range of potentially debilitating symptoms which develop in at least 10% of people who have recovered from acute SARS-CoV-2 infection. This study has quantified corneal sub-basal nerve plexus morphology and dendritic cell (DC) density in patients with and without long COVID.MethodsForty subjects who had recovered from COVID-19 and 30 control participants were included in this cross-sectional comparative study undertaken at a university hospital. All patients underwent assessment with the National Institute for Health and Care Excellence (NICE) long COVID, Douleur Neuropathique 4 (DN4) and Fibromyalgia questionnaires, and corneal confocal microscopy (CCM) to quantify corneal nerve fibre density (CNFD), corneal nerve branch density (CNBD), corneal nerve fibre length (CNFL), and total, mature and immature DC density.ResultsThe mean time after the diagnosis of COVID-19 was 3.7±1.5 months. Patients with neurological symptoms 4 weeks after acute COVID-19 had a lower CNFD (p=0.032), CNBD (p=0.020), and CNFL (p=0.012), and increased DC density (p=0.046) compared with controls, while patients without neurological symptoms had comparable corneal nerve parameters, but increased DC density (p=0.003). There were significant correlations between the total score on the NICE long COVID questionnaire at 4 and 12 weeks with CNFD (ρ=−0.436; p=0.005, ρ=−0.387; p=0.038, respectively) and CNFL (ρ=−0.404; p=0.010, ρ=−0.412; p=0.026, respectively).ConclusionCorneal confocal microscopy identifies corneal small nerve fibre loss and increased DCs in patients with long COVID, especially those with neurological symptoms. CCM could be used to objectively identify patients with long COVID.

BackgroundThis study was conducted to systematically review the existing literature examining the prevalence of anxiety among hospital staff and identifying the contributing factors to address the complications of this disorder and develop effective programmes for reducing the complications of this mental health problem.MethodsWe searched the electronic databases including PubMed, EMBASE, Scopus, Web of Science and Google Scholar from January 2020 to February 2021. To perform meta-analysis, the random effects model was used. To assess the statistical heterogeneity of the included studies, the I2index was used, and 95% CI was estimated. Data analysis was performed by R software.ResultsIn the final analysis, 46 articles with the total sample size of 61 551 hospital staff members were included. Accordingly, anxiety prevalence among healthcare workers (HCWs) was 26.1% (95% CI 19% to 34.6%). The prevalence rates of anxiety in health technicians and medical students were 39% (95% CI 13% to 73%) and 36% (95% CI 15% to 65%), respectively, indicating a much higher prevalence than other hospital staff members. Furthermore, a positive significant relationship between prevalence of anxiety among HCWs and their age was approved (pConclusionThe findings show a moderately high prevalence rate of anxiety in hospital staff. Due to the high prevalence of this mental health problem in health technicians, medical students and frontline health workers, it is highly suggested that healthcare institutions offer mental health programmes for these working groups in order to appropriately manage anxiety during the COVID-19 pandemic.

BackgroundA need arose to divert patients with psychiatric complaints from the emergency department to alternative settings for psychiatric consultations to reduce footfall during COVID-19. We assessed the effectiveness of alternative referral pathway in reducing COVID-19 infection in our service and its effect on service quality: response time and number of patients leaving before the review. We evaluated the satisfaction of patients, general practitioners (GPs) and mental health service staff with the pathway.MethodsAll patients referred to the mental health service over a 2-month period following the introduction of the pathway were included. Findings were compared against the cohort referred for emergency assessment during the same period in 2019. Feedback surveys were distributed to patients, staff and GPs. χ2 and independent sample t-test were used to compare the variables.ResultsOver 2 months, 255 patients received an emergency assessment via the pathway, representing a 22.3% decrease in the volume of presentations from the same period in 2019. There were no COVID-19 cases among our patients or staff on the roster for assessing patients. In comparison to 2019, response times were improved (pConclusionThe pathway was successful in reducing the spread of infection, improving response times and reducing the numbers of patients who left without an assessment. Given the improved outcomes and acceptability, this is a preferable pathway for emergency referrals into the future.

IntroductionTo understand the impact of e-cigarette devices, flavours, nicotine levels and prices on adult e-cigarette users’ choices among closed-system and open-system e-cigarettes, cigarettes and heated tobacco products (HTPs).MethodsOnline discrete choice experiments were conducted among adult (≥18 years) e-cigarette users (n=2642) in August 2020. Conditional logit regressions were used to assess the relative impact of product attributes and the interactions between product attributes and user characteristics, with stratified analyses to examine differences by smoking status and primarily used e-cigarette device and flavour.ResultsOn average, participants preferred non-tobacco and non-menthol flavours most, preferred open-system over closed-system e-cigarettes and preferred regular nicotine level over low nicotine level. However, the preference varied by demographics, smoking status and the primarily used e-cigarette device and flavour. The differences in preference among products/devices were larger than the difference among flavours or nicotine levels. Participants who primarily used closed-system e-cigarettes exhibited similar preferences for closed-system and open-system e-cigarettes, but those who primarily used open-system e-cigarettes preferred much more open-system over closed-system e-cigarettes. HTP was the least preferred product, much lower than cigarettes in general, but participants living in states where IQOS is being sold had similar preferences to cigarettes and HTPs.ConclusionsPeople are unlikely to switch to another product/device because of the restriction of flavour or nicotine level. If non-tobacco and non-menthol flavours were banned from open-system e-cigarettes, users may switch to menthol flavour e-cigarettes. Intervention strategies should be tailored to specific groups.

After 40 years of attributing high rates of physician career dissatisfaction, attrition, alcoholism, divorce and suicide to ‘burnout’, there is growing recognition that these outcomes may instead be caused by moral injury. This has led to a debate about the relative diagnostic merits of these two terms, a recognition that interventions designed to treat burnout may be ineffective, and much perplexity about how—if at all—this changes anything.The current research seeks to develop the construct of moral injury outside military contexts, generate more robust validity tests and more fully describe and measure the experiences of persons exposed to moral harms. Absent from the literature is a mechanism through which to move from the collective moral injury experience of physicians to a systematic change in the structure of medical practice. To address this, after providing a brief history, definitions and contrasts between burnout, moral distress and moral injury, we review the interplay of moral and ethical codes in the context of moral injury. We conclude by suggesting that professional associations can potentially prevent moral injury by providing protections for physicians within their codes of ethics.

ObjectiveWaiting time is inevitable during cardiovascular (CV) care. This study examines whether waiting room-based CV education could complement CV care.MethodsA 2:1 randomised clinical trial of patients in waiting rooms of hospital cardiology clinics. Intervention participants received a series of tablet-delivered CV educational videos and were randomised 1:1 to receive another video on cardiopulmonary resuscitation (CPR) or no extra video. Control received usual care. The primary outcome was the proportion of participants reporting high motivation to improve CV risk-modifying behaviours (physical activity, diet and blood pressure monitoring) post-clinic. Secondary outcomes: clinic satisfaction, CV lifestyle risk factors (RFs) and confidence to perform CPR. Assessors were blinded to treatment allocation.ResultsAmong 514 screened, 330 were randomised (n=220 intervention, n=110 control) between December 2018 and March 2020, mean age 53.8 (SD 15.2), 55.2% male. Post-clinic, more intervention participants reported high motivation to improve CV risk-modifying behaviours: 29.6% (64/216) versus 18.7% (20/107), relative risk (RR) 1.63 (95% CI 1.04 to 2.55). Intervention participants reported higher clinic satisfaction RR: 2.19 (95% CI 1.45 to 3.33). Participants that received the CPR video (n=110) reported greater confidence to perform CPR, RR 1.61 (95% CI 1.20 to 2.16). Overall, the proportion of participants reporting optimal CV RFs increased between baseline and 30-day follow-up (16.1% vs 24.8%, OR=2.44 (95% CI 1.38 to 4.49)), but there was no significant between-group difference at 30 days.ConclusionCV education delivery in the waiting room is a scalable concept and may be beneficial to CV care. Larger studies could explore its impact on clinical outcomes.Trial registration numberANZCTR12618001725257.

ObjectiveTo investigate the perceptions of young people and adults, smokers and non-smokers about the current set of innovations introduced in 2018 into the Brazilian tobacco products’ health warnings.MethodsTwenty focus groups were conducted in five state capitals in Brazil. The participants (n=163) were segmented by smoking status, age (15–17 years, 18–55 years) and social grade (C, D–E classes) to examine cigarette packaging and explore the participants’ perceptions of health warnings.ResultsHealth warnings capture attention, eliciting apprehension, fear, disgust and concern about the negative consequences of cigarette consumption. The 2018 Brazil health warnings are spontaneously recalled by participants, even without the presence of cigarette packages. However, the analysis also reveals the challenges of overcoming communication barriers and distorted interpretations, especially among smokers. The inclusion of direct and provocative stimuli, such as the use of the word ‘you’, attracts attention and creates more proximity to the recipient of the message. The results also highlight the interest and fear elicited by warnings on toxic constituents and the importance of using contrasting colours in warnings, which differentiate them from the colours of cigarette packs.ConclusionIntroducing innovative components in health warnings can catch consumers’ attention but considering that the interviewees encountered difficulties interpreting textual warnings about toxic constituents in cigarettes, the study reinforces the importance of adopting direct language and pictures, instead of text, which can visually transmit the warning messages and the use of specific wording that generates proximity between the emitter and receiver.

BackgroundGlobally, the measurement of quality is an important process that supports the provision of high-quality and safe healthcare services. The requirement for valid quality measurement to gauge improvements and monitor performance is echoed in the Australian prehospital care setting. The aim of this study was to use an evidence-informed expert consensus process to identify valid quality indicators (QIs) for Australian prehospital care provided by ambulance services.MethodsA modified RAND/UCLA appropriateness method was conducted with a panel of Australian prehospital care experts from February to May 2019. The proposed QIs stemmed from a scoping review and were systematically prepared within a clinical and non-clinical classification system, and a structure/process/outcome and access/safety/effectiveness taxonomy. Rapid reviews were performed for each QI to produce evidence summaries for consideration by the panellists. QIs were deemed valid if the median score by the panel was 7–9 without disagreement.ResultsOf 117 QIs, the expert panel rated 84 (72%) as valid. This included 26 organisational/system QIs across 7 subdomains and 58 clinical QIs within 10 subdomains.Most QIs were process indicators (n=62; 74%) while QIs describing structural elements and desired outcomes were less common (n=13; 15% and n=9; 11%, respectively). Non-exclusively, 18 (21%) QIs addressed access to healthcare, 21 (25%) described safety aspects and 64 (76%) specified elements contributing to effective services and care. QIs on general time intervals, such as response time, were not considered valid by the panel.ConclusionThis study demonstrates that with consideration of best available evidence a substantial proportion of QIs scoped and synthesised from the international literature are valid for use in the Australian prehospital care context.

ObjectivesThe balloon-expandable Sapien-3 valve demonstrated superior results in terms of residual aortic regurgitation when compared with self-expandable devices. We aimed to compare for the first-time early outcomes of Sapien-3 transcatheter heart valve (THV) with the balloon-expandable Myval device.MethodsConsecutive real-world patients from nine European institutions with symptomatic severe aortic stenosis treated either with Sapien-3 or Myval THV devices after June 2018 were compared. Early clinical outcomes were prospectively gathered and blinded analysis of 30-day echocardiography was conducted. Matching for the following variables was performed: age, body surface area, Society of Thoracic Surgeons risk score, left ventricular function, mean gradient, transfemoral approach, aortic valvular calcium, aortic annulus mean diameter, area and eccentricity index.ResultsA total of 416 patients treated either with the Sapien-3 (n=286, 68.7%) or with Myval THV (n=130, 31.3%) were included and 103 pairs compared after matching. Baseline characteristics were similar. Procedural success rate (Sapien-3: 94.2%; Myval: 93.2%, p=0.219), 30-day mortality (Sapien-3: 2.9%; Myval: 0.97%, p=0.625), clinical efficacy (12.6 vs 4.9%, p=0.057) and early safety (12.6 vs 4.9%, p=0.096) were comparable. There was a lower need for new permanent pacemaker (15.5 vs 5.8% p=0.020) with Myval. No significant differences were found in terms of ≥moderate aortic regurgitation (1% for Sapien-3, 0% for Myval, p=0.314), but mean gradients were higher following Sapien-3 than after Myval (pConclusionsThe new Myval balloon-expandable THV was favourable in terms of safety, with low rate of permanent pacemaker and with favourable residual gradients and paravalvular leak rate according to blinded echocardiographic analysis.

ObjectiveTo assess the current evidence for the efficacy of care bundles in reducing unplanned extubations (UEs) in critically ill children.DesignSystematic review according to the Cochrane guidelines and meta-analysis using random-effects modelling.MethodsWe searched MEDLINE, EMBASE, CINAHL, Web of Science, Scopus, Cochrane and SciELO databases from inception until April 2021. We conducted a quality appraisal for each study using the Newcastle–Ottawa Scale and Standards for Quality Improvement Reporting Excellence (SQUIRE) V.2.0 checklist.Main outcomeThe primary outcome measure was UE rates per 100 intubation days.ResultsWe screened 10 091 records and finally included 11 studies. Six studies were pre/post-intervention studies, and five were interrupted time-series studies. The methodological quality was ‘good’ in 70%, and the remaining as ‘fair’ (30%). The most frequently used implementation strategies were staff education (100%), root cause analysis (100%), and audit and feedback (82%). Key bundle care components comprised identification of high-risk patients, endotracheal tube care and sedation protocol. Not all studies fully completed the SQUIRE V.2.0 checklist. Meta-analysis revealed a reduction in UE rate following the introduction of care bundles (rate ratio: 0.40 (95% CI: 0.19 to 0.84); p=0.02), which equates to a 60% reduction in UE rates.ConclusionsWe found that identifying high-risk patients, endotracheal tube care and protocol-directed sedation are core elements in care bundles for preventing UEs. However, there are several methodological gaps in the literature, including poor evaluation of adherence to bundle components. Future studies should address these gaps to strengthen their validity.

ObjectivesWe investigated haemodynamics and clinical outcomes according to type of pulmonary hypertension (PH) in patients with constrictive pericarditis (CP).BackgroundAs the prevalence of CP with concomitant myocardial disease (mixed CP) grows, PH is more commonly seen in patients with CP. However, haemodynamic and outcome data according to the presence or absence of PH are limited.Methods150 patients with surgically confirmed CP who underwent echocardiography and cardiac catheterisation within 7 days at two tertiary centres were divided into three groups: no-PH, isolated postcapillary PH (Ipc-PH) and combined postcapillary and precapillary PH (Cpc-PH). Primary outcome was all-cause mortality during follow-up.ResultIn this retrospective cohort study, 110 (73.3%) had PH (mean pulmonary artery pressure ≥25 mm Hg). Cpc-PH, using defined cut-offs for pulmonary vascular resistance (>3 Wood units) or diastolic pulmonary gradient (≥7 mm Hg), was seen in 18 patients (12%). The Cpc-PH group had a higher prevalence of comorbidities (diabetes and atrial fibrillation) and concomitant myocardial disease as an aetiology of CP than other groups. Pulmonary vascular resistance had a significant direct correlation with medial E/e′ by Doppler echocardiography (r=0.404, pConclusionCombined postcapillary and precapillary PH develops in a subset of patients with CP and is associated with long-term mortality after pericardiectomy.

ObjectiveCochleovestibulopathy is a distinguishable paraneoplastic phenotype. In this study, we evaluate clinical presentation, serological/cancer associations and outcomes of paraneoplastic cochleovestibulopathy.MethodsRetrospective chart review of patients with hearing impairment and/or vestibulopathy who underwent serological evaluations for paraneoplastic antibodies between January 2007 and February 2021 was performed.ResultsTwenty-six patients were identified (men, n=23; median age, 45 years, range: 28–70). Biomarkers detected included: KLHL11-IgG‌ ‌(n=20,‌ ‌77% (coexisting LUZP4-IgG, n=8)),‌ ‌‌ANNA1-IgG‌ ‌ ‌(n=3,‌ ‌12%),‌ ‌amphiphysin-IgG‌‌ ‌(n=2,‌ ‌8%)‌ ‌and‌ ‌LUZP4-IgG‌‌ ‌(n=1,‌ ‌4%). Most common neoplastic association was ‌testicular‌/‌extra-testicular‌ ‌seminoma‌ ‌ (n=13,‌ ‌50%).‌‌ Hearing‌ impairment (bilateral, 62%) was ‌present‌ ‌in‌ ‌all‌ ‌patients.‌ ‌Fifteen patients (58%) had cochleovestibular dysfunction as their initial presentation before rhombencephalitis/encephalomyelitis manifestations (hearing loss, four; acute vertigo, eight; both, three). ‌Brain‌ ‌MRI‌ ‌demonstrated‌ ‌internal‌ ‌auditory‌ ‌canal‌ ‌enhancement‌ ‌in‌ ‌four ‌patients.‌ Audiometry commonly revealed severe-profound bilateral sensorineural hearing loss. Most patients ‌had‌ a refractory course ‌despite‌ ‌immunotherapy‌ ‌and/or‌ ‌cancer‌ ‌treatment‌.ConclusionCochleovestibulopathy commonly presents with rapidly progressive bilateral hearing loss and/or acute vertigo. However, in some patients, these symptoms present along with or following brainstem/cerebellar manifestations. KLHL11-IgG and seminoma are the most common serological and cancer associations, respectively. Recognition of this phenotype may aid in earlier diagnosis of paraneoplastic autoimmunity and associated cancer.

BackgroundThis randomized trial compared ultrasound-guided pericapsular nerve group block and suprainguinal fascia iliaca block in patients undergoing primary total hip arthroplasty. We selected the postoperative incidence of quadriceps motor block (defined as paresis or paralysis of knee extension) at 6 hours as the primary outcome. We hypothesized that, compared with suprainguinal fascia iliaca block, pericapsular nerve group block would decrease its occurrence from 70% to 20%.MethodsForty patients undergoing primary total hip arthroplasty under spinal anesthesia were randomly allocated to receive a pericapsular nerve group block (n=20) using 20 mL of adrenalized levobupivacaine 0.50%, or a suprainguinal fascia iliaca block (n=20) using 40 mL of adrenalized levobupivacaine 0.25%. After the performance of the block, a blinded observer recorded pain scores at 3, 6, 12, 18, 24, 36, and 48 hours; cumulative breakthrough morphine consumption at 24 and 48 hours; opioid-related side effects; ability to perform physiotherapy at 24 and 48 hours; as well as length of stay. Furthermore, the blinded observer also carried out sensory assessment (of the anterior, lateral, and medial aspects of the mid-thigh) and motor assessment (knee extension and hip adduction) at 3, 6, and 24 hours.ResultsCompared with suprainguinal fascia iliaca block, pericapsular nerve group block resulted in a lower incidence of quadriceps motor block at 3 hours (45% vs 90%; pConclusionFor primary total hip arthroplasty, pericapsular nerve group block results in better preservation of motor function than suprainguinal fascia iliaca block. Additional investigation is required to elucidate the optimal local anesthetic volume for motor-sparing pericapsular nerve group block and to compare the latter with alternate motor-sparing strategies such as periarticular local anesthetic infiltration.Trial registration numberNCT04402450.

Background and objectivesWhile there are several published recommendations and guidelines for trainees undertaking subspecialty Fellowships in regional anesthesia, a similar document describing a core regional anesthesia curriculum for non-fellowship trainees is less well defined. We aimed to produce an international consensus for the training and teaching of regional anesthesia that is applicable for the majority of worldwide anesthesiologists.MethodsThis anonymous, electronic Delphi study was conducted over two rounds and distributed to current and immediate past (within 5 years) directors of regional anesthesia training worldwide. The steering committee formulated an initial list of items covering nerve block techniques, learning objectives and skills assessment and volume of practice, relevant to a non-fellowship regional anesthesia curriculum. Participants scored these items in order of importance using a 10-point Likert scale, with free-text feedback. Strong consensus items were defined as highest importance (score ≥8) by ≥70% of all participants.Results469 participants/586 invitations (80.0% response) scored in round 1, and 402/469 participants (85.7% response) scored in round 2. Participants represented 66 countries. Strong consensus was reached for 8 core peripheral and neuraxial blocks and 17 items describing learning objectives and skills assessment. Volume of practice for peripheral blocks was uniformly 16–20 blocks per anatomical region, while ≥50 neuraxial blocks were considered minimum.ConclusionsThis international consensus study provides specific information for designing a non-fellowship regional anesthesia curriculum. Implementation of a standardized curriculum has benefits for patient care through improving quality of training and quality of nerve blocks.

BackgroundWe hypothesised that occupational exposures differently affect subtypes of adult-onset asthma.ObjectiveWe investigated potential relations between occupation and three subtypes of adult asthma, namely atopic asthma, non-atopic asthma and asthma–COPD overlap syndrome (ACOS).MethodsThis is a population-based case–control study of incident asthma among working-age adults living in Pirkanmaa Hospital District in Southern Finland. The determinant of interest was occupation at the time of diagnosis of asthma or the job that the subject had quit due to respiratory symptoms. Asthma was divided into three mutually exclusive subtypes on the basis of any positive IgE antibody (atopic and non-atopic asthma) and presence of persistent airways obstruction in spirometry (ACOS). We applied unconditional logistic regression analysis to estimate adjusted OR (aOR), taking into account gender, age and smoking.ResultsThe following occupational groups showed significantly increased risk of atopic asthma: chemical industry workers (aOR 15.76, 95% CI 2.64 to 94.12), bakers and food processors (aOR 4.69, 95% CI 1.18 to 18.69), waiters (aOR 4.67, 95% CI 1.40 to 15.56) and those unemployed (aOR 3.06, 95% CI 1.52 to 6.17). The following occupations showed clearly increased risk of non-atopic asthma: metal workers (aOR 8.37, 95% CI 3.77 to 18.59) and farmers and other agricultural workers (aOR 2.36, 95% CI 1.10 to 5.06). Some occupational groups showed statistically significantly increased OR of ACOS: electrical and electronic production workers (aOR 30.6, 95% CI 6.10 to 153.35), fur and leather workers (aOR 16.41, 95% CI 1.25 to 215.85) and those retired (aOR 5.55, 95% CI 1.63 to 18.97).ConclusionsOur results show that different occupations are associated with different subtypes of adult-onset asthma.

IntroductionIn the UK, since 20 May 2017, tobacco companies must sell cigarettes and rolling tobacco in standardised packs.MethodsThree waves of a longitudinal online survey with smokers (≥16) before standardised packaging (wave 1 (W1): April to May 2016) and after standardised packaging (wave 2 (W2): September to November 2017; wave 3 (W3): May to July 2019). Of the 6233 smokers at W1, 4293 responded at W2 and 3175 at W3. We explored smokers’ response to warning salience, appeal (appeal, quality, value, satisfaction and taste compared with a year ago), harm (harmfulness compared with a year ago, harm compared with other brands and whether some brands have more harmful substances), and quit plans, attempts and quitting.ResultsCompared with W1, the proportions noticing warnings first on packs, and rating cigarettes/rolling tobacco less appealing and worse value than a year ago, were higher at W2 and W3. Disagreeing that some brands contain more harmful substances was higher at W2. Interactions between social grade and survey wave for warning salience, and each appeal and harm outcome, were non-significant. Smokers switching from not noticing warnings first at W1 to noticing warnings first at W2, or who had a lower composite appeal score at W2, were more likely to plan to quit and to have made a quit attempt at W2. Smokers who switched to disagreeing that some brands contain more harmful substances at W2, after giving a different response at W1, were more likely to quit at W3.ConclusionsStandardised packaging appears to be having the intended impacts.