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Physical activity (PA) improves dyspnoea, psychological wellbeing and quality of life (QoL) for people with COPD reducing their risk of exacerbation. However, engagement in PA is low especially amongst those with anxiety and depression, and PA programmes are limited in countries with limited resources such as Brazil. We explored perceptions of 21 people with COPD about the impact of their disease on taking part in community-based PA programmes in Sao Paulo, Brazil through semi-structured telephone interviews from October 2020 to April 2021. Discussions were audio-recorded, transcribed, and analysed using the Framework method. Five themes were identified: Knowledge about COPD and its management; Self-perception of life with COPD; Knowledge and experiences of depression and anxiety; Opinions on PA and repercussions of COVID-19. PA was considered to be important in bringing physical and mental health benefits but there were barriers in accessibility of formal PR programmes and therefore local community PA programmes were considered to be important. People with mental health conditions tended to view PA more negatively. COVID-19 had reduced PA opportunities, access to COPD treatment and social interaction, and was associated with more exacerbations and emotional suffering. In general, this study showed an urgent need to improve knowledge about COPD and its risk factors and management among both patients, the public and primary healthcare professionals. We provide important content for the formulation of public policies for the implementation of specific activity programmes for people with COPD in community spaces using local resources and intersectoral partnerships. [ABSTRACT FROM AUTHOR]

Effective conservation planning is often predicated on detailed and current information about a species’ geographical distribution. However, traditional sources of occurrence data (e.g., online biodiversity databases) may be insufficient for estimating the range of rare, poorly understood species that are readily misidentified. Here, we demonstrate a more holistic approach to this problem, using the poorly known glossy grass skink (Pseudemoia rawlinsoni) as a case study. We first compared the relative contribution made (to our geographical knowledge of the species) by online database records, with that of photo-substantiated records obtained via personal communication (PC). We used ecological niche modelling (ENM) to predict the species’ distribution, then performed field surveys at both historical and predicted suitable sites to further clarify its occurrence. 20% of all known records came from the PC method, which resulted in 35 new sites and increased the species’ area of occupancy (AOO) by 176 km². Most records obtained via PC came from the past decade, demonstrating that this method is more effective at elucidating the current distribution. ENM revealed that P. rawlinsoni has a disjunct range, and is mostly a low-elevation coastal species, with the exception of suitable habitat in parts of the high-elevation Australian Alps bioregion. The species’ AOO has likely declined over recent decades owing to anthropogenic disturbance, given that 38% of the species’ predicted range is now cleared agricultural land, and our field surveys failed to detect the species at 52% of historical record sites. Together, these findings provide a robust foundation of geographical knowledge on which to develop strategic conservation actions for the species. [ABSTRACT FROM AUTHOR]

Background: Modern general practice is characterised by increased demand and growing multi-disciplinarity, including ring-fenced funding for additional non-clinical roles. However, for practice receptionists training has remained unchanged for decades, yet primary care is under greater pressure than ever with receptionists becoming a growing focal point of abuse and unprecedented numbers leaving the role., Aim: To present the evidence of the range of tasks that receptionists continue to perform, describing their impact on primary care delivery and how the role might be better supported., Method: We conducted a systematic review of evidence contained in the major medical databases (Medline/PubMed, CINAHL, ASSIA, Cochrane Library, and EMBASE) up until July 2023, including hand searches of the bibliographies of included studies., Results: We identified 28 studies which we grouped into three themes: Service delivery, confirming the continuing role of receptionists in providing administrative support alongside clinical tasks of prioritising patients for consultations, facilitating repeat prescriptions, and communicating blood test results; Patient attitudes describing how patient's lacked trust in receptionists viewed as unqualified and unnecessarily obstructive; Finally, in considering Receptionist experience, the contrast between their confidence in performing administrative roles and the anxiety induced from the clinically related tasks was described, particularly the mounting pressure from patients to meet their preferences for clinician appointments., Conclusion: Though confident performing administrative tasks, receptionists described the uncertainty and anxiety when providing clinically oriented support or managing patients when their requests for appointments could not be met. More appropriate training or professionalisation might improve staff retainment., (Copyright © 2024, The Authors.)

This article is the second instalment in the series. The preceding article detailed the background, methodology and methods, while the current article delves into the study's findings and alignment with the broader literature. The study aimed to explore the research question: 'how do men perceive their engagement in the self-management of non-cancer-related lymphoedema?' Upon completing an online survey based on the validated lymphoedema quality of life tool (LYMQoL), the gathered data underwent narrative thematic analysis. Three themes emerged: Theme 1 explored the strategies men use to address the psychological impact of self-care, including physical concealment. Theme 2 focused on the use of physical control as a method for managing perceived vulnerability. Theme 3 centred on relationships within self-care. The findings shed light on the intricate nature of self-care in the context of lymphoedema and its impact on masculinity. These insights resonate with existing literature, emphasising the use of available resources driven by the perceived vulnerability men experience in their lives.

Purpose: The purpose of this systematic review is to better understand access to, acceptance of and adherence to cancer prehabilitation., Methods: MEDLINE, CINAHL, PsychINFO, Embase, Physiotherapy Evidence Database, ProQuest Medical Library, Cochrane Library, Web of Science and grey literature were systematically searched for quantitative, qualitative and mixed-methods studies published in English between January 2017 and June 2023. Screening, data extraction and critical appraisal were conducted by two reviewers independently using Covidence™ systematic review software. Data were analysed and synthesised thematically to address the question 'What do we know about access, acceptance and adherence to cancer prehabilitation, particularly among socially deprived and minority ethnic groups?' The protocol is published on PROSPERO CRD42023403776 RESULTS: Searches identified 11,715 records, and 56 studies of variable methodological quality were included: 32 quantitative, 15 qualitative and nine mixed-methods. Analysis identified facilitators and barriers at individual and structural levels, and with interpersonal connections important for prehabilitation access, acceptance and adherence. No study reported analysis of facilitators and barriers to prehabilitation specific to people from ethnic minority communities. One study described health literacy as a barrier to access for people from socioeconomically deprived communities., Conclusions: There is limited empirical research of barriers and facilitators to inform improvement in equity of access to cancer prehabilitation., Implications for Cancer Survivors: To enhance the inclusivity of cancer prehabilitation, adjustments may be needed to accommodate individual characteristics and attention given to structural factors, such as staff training. Interpersonal connections are proposed as a fundamental ingredient for successful prehabilitation., (© 2024. The Author(s).)

This initial article delves into the methodology, methods and theories, while the subsequent article will centre on the discoveries, discussion and conclusion. The study aimed to address the research question: how do men perceive their engagement in the self-management of non-cancer-related lymphoedema? An interpretivist qualitative methodology was employed, utilising an online survey based on the validated lymphoedema quality of life tool (LYMQoL). The data underwent inductive narrative inquiry. The study incorporated theories such as hegemonic masculinity and the health, illness, men and masculinities (HIMM) framework. The findings will be detailed in the second article in this series. This article has delineated the objective, methodologyand methods, employing a qualitative interpretivist approach through narrative inquiry. The study incorporated masculinity theories, including hegemonic masculinity and HIMM. The second article will present the findings and their significance within the broader literature.

Background: Given that signage, messaging, and advertisements (ads) are the gateway to many interventions in suicide prevention, it is important that we understand what type of messaging works best for whom., Objective: We investigated whether explicitly mentioning suicide increases engagement using internet ads by investigating engagement with campaigns with different categories of keywords searched, which may reflect different cognitive states., Methods: We ran a 2-arm study Australia-wide, with or without ads featuring explicit suicide wording. We analyzed whether there were differences in engagement for campaigns with explicit and nonexplicit ads for low-risk (distressed but not explicitly suicidal), high-risk (explicitly suicidal), and help-seeking for suicide keywords., Results: Our analyses revealed that having explicit wording has opposite effects, depending on the search terms used: explicit wording reduced the engagement rate for individuals searching for low-risk keywords but increased engagement for those using high-risk keywords., Conclusions: The findings suggest that individuals who are aware of their suicidality respond better to campaigns that explicitly use the word "suicide." We found that individuals who search for low-risk keywords also respond to explicit ads, suggesting that some individuals who are experiencing suicidality search for low-risk keywords., (©Sandersan Onie, Susanne Oliver Armstrong, Natasha Josifovski, Patrick Berlinquette, Nicola Livingstone, Sarah Holland, Coco Finemore, Nyree Gale, Emma Elder, George Laggis, Cassandra Heffernan, Adam Theobald, Michelle Torok, Fiona Shand, Mark Larsen. Originally published in JMIR Mental Health (https://mental.jmir.org), 19.03.2024.)

Background: Within primary care there exists a cohort of patients misdiagnosed with Chronic Obstructive Pulmonary Disease (COPD). Misdiagnosis can have a detrimental impact on healthcare finances and patient health and so understanding the factors leading to misdiagnosis is crucial in order to reduce misdiagnosis in the future. The objective of this study is to understand and explore the perceived causes of COPD misdiagnosis in primary care., Methods: A sequential mixed methods study, quantifying prevalence and features of patients misdiagnosed with COPD in primary care followed by a qualitative analysis to explore perceived causes of misdiagnosis. Quantitative data was collected for 206 patients identified as misdiagnosed with COPD within the INTEGR COPD study (NCT03482700). Qualitative data collected from 21 healthcare professionals involved in providing COPD care and 8 misdiagnosed patients who were recruited using a maximum variation purposive sampling., Results: Misinterpretation of spirometry results was the prevailing factor leading to patients initially being misdiagnosed with COPD, affecting 59% of misdiagnosed patients in this cohort. Of the 99 patients who were investigated for their underlying diagnosis; 41% had normal spirometry and 40% had asthma. Further investigation through qualitative methodology uncovered reluctance to challenge historical misdiagnoses and challenges in differential diagnosis as the underlying explanations for COPD misdiagnosis in this cohort., Conclusions: Patients historically diagnosed with COPD without spirometric evidence are at risk of remaining labelled and treated for COPD despite non-obstructive respiratory physiology, leading to a persistent cohort of patients misdiagnosed with COPD in primary care. The lack of spirometry services during and after the COVID19 pandemic in primary care risks adding to the cohort of misdiagnosed patients. Support from respiratory specialists can potentially help to reduce the prevalence of COPD misdiagnosis in primary care., Trial Registration: NCT03482700., Competing Interests: The authors have read the journal’s policy and have the following competing interests: AMT and KP were supported financially in relation to this study through a non-commercial grant from AstraZeneca. AMT has received grants not in relation to this study from Chiesi, NIHR ARC & PSRC, CSL Behring and Grifols Biotherapeutics. DJS, CCH, SDC, AP, APD and NG declare no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Patel et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Aims: To codesign a cancer personalised activity and lifestyle tool (CAN-PAL) based on an existing tool. To help cancer care workers support people affected by cancer to plan and integrate physical activity into lifestyles., Design: Mixed-methods codesign study., Methods: Phase 1: Focus groups with people affected by cancer (n = 10) or interviews (n = 2) to discuss suitable physical activities and adaptation of the existing tool. Data were recorded, transcribed and analysed thematically. Themes informed the design of the prototype CAN-PAL and user guide. Phase 2: Healthcare professionals considered the potential use of the CAN-PAL prototype and completed an online survey including the system usability scale and free text responses., Results: Phase 1: Identified suitable physical activities and four themes were identified including: Capability, benefits, barriers and resources which informed the prototype CAN-PAL and user guide. Phase 2: The user survey was completed by 12 healthcare professionals. Median (range) system usability scale was 80 (50-95) (best score 100), scores >68 indicate good or better usability. Themes from the free text comments included strengths, amendments, considerations and limitations. Results were used to finalise CAN-PAL and the user guide., Conclusion: The codesigned CAN-PAL tool had good usability. Further work is needed to evaluate the impact of CAN-PAL on activity levels and behaviour in people affected by cancer., Relevance to Clinical Practice: People affected by cancer need support to undertake physical activity. The purpose of CAN-PAL is to assist cancer care workers to support people affected by cancer to plan and integrate physical activity into lifestyles., Patient or Public Contribution: Public partners considered the findings from Phase 1 and 2 and informed the design of the prototype, final CAN-PAL and user guide and coauthored the paper., Reporting Method: The study adhered to relevant EQUATOR guidelines; the study was reported according to the COREQ checklist., (© 2023 The Authors. Journal of Clinical Nursing published by John Wiley & Sons Ltd.)

Background: Effective stakeholder engagement in health research is increasingly being recognised and promoted as an important pathway to closing the gap between knowledge production and its use in health systems. However, little is known about its process and impacts, particularly in low-and middle-income countries. This opinion piece draws on the stakeholder engagement experiences from a global health research programme on Chronic Obstructive Pulmonary Disease (COPD) led by clinician researchers in Brazil, China, Georgia and North Macedonia, and presents the process, outcomes and lessons learned., Main Body: Each country team was supported with an overarching engagement protocol and mentored to develop a tailored plan. Patient involvement in research was previously limited in all countries, requiring intensive efforts through personal communication, meetings, advisory groups and social media. Accredited training programmes were effective incentives for participation from healthcare providers; and aligning research findings with competing policy priorities enabled interest and dialogue with decision-makers. The COVID-19 pandemic severely limited possibilities for planned engagement, although remote methods were used where possible. Planned and persistent engagement contributed to shared knowledge and commitment to change, including raised patient and public awareness about COPD, improved skills and practice of healthcare providers, increased interest and support from clinical leaders, and dialogue for integrating COPD services into national policy and practice., Conclusion: Stakeholder engagement enabled relevant local actors to produce and utilise knowledge for small wins such as improving day-to-day practice and for long-term goals of equitable access to COPD care. For it to be successful and sustained, stakeholder engagement needs to be valued and integrated throughout the research and knowledge generation process, complete with dedicated resources, contextualised and flexible planning, and commitment., (© 2024. The Author(s).)

Introduction: In care settings across the globe non-clinical staff are involved in filtering patients to the most appropriate source of care. This includes primary care where general practice receptionists are key in facilitating access to individual surgeries and the wider National Health Service. Despite the complexity and significance of their role little is known of how the decision-making behaviors of receptionists impact policy implementation and service delivery. By combining the agent-based implementation theory of street-level bureaucracy with a tri-level analytical framework this work acknowledges the impact of the decisions made by receptionists as street-level bureaucrats and demonstrates the benefits of using the novel framework to provide practical insight of the factors influencing those decisions., Methods: A secondary analysis of qualitative data gathered from a series of semi-structured interviews conducted with 19 receptionists in the United Kingdom in 2019 was used to populate a tri-level framework: the micro-level relates to influences on decision making acting at an individual level, the meso-level influences at group and organizational levels, and the macro-level influences at a societal or policy level., Results: At the micro-level we determined how receptionists are influenced by the level of rapport developed with patients and would use common sense to interpret urgency. At the meso-level , influences included their position at the forefront of premises, the culture of the workplace, and the processes and protocols used by their practice. At the macro-level , participants described the impact of limited health service capacity, the lack of mandatory training, and the growth in the use of digital technologies., Conclusions: Street-level bureaucracy, complemented with a tri-level contextual analysis, is a useful theoretical framework to understand how health workers, such as receptionists, attempt to provide universality without sufficient resource, and could potentially be applied to other kinds of public service workers in this way. This theoretical framework also benefits from being an accessible foundation on which to base practice and policy changes., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Authors.)

Introduction: In 2019, smoking prevalence in North Macedonia was one of the world's highest at around 46% in adults. However, access to smoking cessation treatment is limited and no co-ordinated smoking cessation programmes are provided in primary care., Methods: We conducted a three parallel-armed randomised controlled trial (n = 1368) to investigate effectiveness and cost-effectiveness of lung age (LA) or exhaled carbon monoxide (CO) feedback combined with very brief advice (VBA) to prompt smoking cessation compared with VBA alone, delivered by GPs in primary care in North Macedonia. All participants who decided to attempt to quit smoking were advised about accessing smoking cessation medications and were also offered behavioural support as part of the "ACT" component of VBA. Participants were aged ≥ 35 years, smoked ≥ 10 cigarettes per day, were recruited from 31 GP practices regardless of motivation to quit and were randomised (1:1:1) using a sequence generated before the start of recruitment. The primary outcome was biochemically validated 7-day point prevalence abstinence at 4 weeks (wks). Participants and GPs were not blinded to allocation after randomisation, however outcome assessors were blind to treatment allocation., Results: There was no evidence of a difference in biochemically confirmed quitting between intervention and control at 4wks (VBA + LA RR 0.90 (97.5%CI: 0.35, 2.27); VBA + CO RR 1.04 (97.5%CI: 0.44, 2.44)), however the absolute number of quitters was small (VBA + LA 1.6%, VBA + CO 1.8%, VBA 1.8%). A similar lack of effect was observed at 12 and 26wks, apart from in the VBA + LA arm where the point estimate was significant but the confidence intervals were very wide. In both treatment arms, a larger proportion reported a reduction in cigarettes smoked per day at 4wks (VBA + LA 1.30 (1.10, 1.54); VBA + CO 1.23 (1.03, 1.49)) compared with VBA. The point estimates indicated a similar direction of effect at 12wks and 26wks, but differences were not statistically significant. Quantitative process measures indicated high fidelity to the intervention delivery protocols, but low uptake of behavioural and pharmacological support. VBA was the dominant intervention in the health economic analyses., Conclusion: Overall, there was no evidence that adding LA or CO to VBA increased quit rates. However, a small effect cannot be ruled out as the proportion quitting was low and therefore estimates were imprecise. There was some evidence that participants in the intervention arms were more likely to reduce the amount smoked, at least in the short term. More research is needed to find effective ways to support quitting in settings like North Macedonia where a strong smoking culture persists., Trial Registration: The trial was registered at http://www.isrctn.com (ISRCTN54228638) on the 07/09/2018., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Electronic cigarette (EC) aerosol emissions generally contain fewer and lower concentrations of harmful and potentially harmful constituents, compared with cigarette smoke. Further studies are needed to establish whether decreased emissions translate to reduced health risks for EC users. In a cross-sectional study, biomarkers of exposure (BoE) to certain tobacco smoke toxicants and biomarkers of potential harm (BoPH), associated with biological processes linked to the potential development of smoking-related diseases and oxidative stress, were assessed in solus Vuse ECs users and current, former, and never smokers. In total, 213 participants were enrolled, and smoking status was confirmed by urinary cotinine, exhaled carbon monoxide, and N-(2-cyanoethyl)valine levels (EC users and former smokers only). During confinement participants used their usual product (EC or cigarette) as normal and BoE and BoPHs were assessed via blood, 24-h urine, and physiological assessment. Significantly lower levels of all urinary BoE; MHBMA, HMPMA, 3-HPMA, NNN, 3-OH-B[a]P, S-PMA, NNAL (all p < 0.0001), and TNeq (p = 0.0074) were observed in EC users when compared with smokers. Moreover, significantly lower levels were observed in EC users for 3 of the 7 BoPH measured, carboxyhaemoglobin (p < 0.0001), soluble intercellular adhesion molecule-1 (p = 0.0028), and 11-dehydrothromboxane B2 (p = 0.0012), when compared with smokers. As compared with smokers, solus Vuse EC users have significantly lower exposure to tobacco toxicants for the BoE, and 3 BoPH measured. These results add to the weight of evidence supporting EC as part of a tobacco harm reduction strategy., (© 2023. Crown.)

Purpose: There is some evidence of the benefits of physical activity (PA) in patients with lung cancer; however, there is a lack of understanding of acceptable PA for patients with established cachexia and how to facilitate sustainable behaviour change to promote PA. Therefore, this study explored the views of healthcare professionals (HP), patients with lung cancer and cachexia, and their carers on preferences for, barriers and facilitators of homebased PA., Methods: This qualitative study involved ten telephone interviews with HPs and face-to-face interviews with seven patients with lung cancer and cachexia and their carers. Interviews were transcribed and analysed thematically. The Capability, Opportunity, Motivation and Behaviour (COM-B) model was used as a framework for the thematic cross-group analysis., Results: The types of homebased PA suggested by patients with lung cancer and cachexia (n = 7), their carers (n = 7) and HPs (n = 10) were functional, flexible, individualised and initially of short duration and low intensity. PA was influenced by themes within physical and psychological Capability, physical and social Opportunities as well as automatic and reflective Motivation., Conclusion: Based on a behaviour change theory, principles to promote homebased PA were developed. These principles need to be integrated into tools to promote PA in people with lung cancer and weight loss., Implications for Cancer Survivors: The application of the proposed principles by clinicians will promote physical activity, enhancing the function and wellbeing of patients with lung cancer and reducing burden on carers., (© 2023. The Author(s).)

Background: Studies have shown that individuals may search for suicide-related terms on the internet prior to an attempt., Objective: Thus, across 2 studies, we investigated engagement with an advertisement campaign designed to reach individuals contemplating suicide., Methods: First, we designed the campaign to focus on crisis, running a campaign for 16 days in which crisis-related keywords would trigger an ad and landing page to help individuals find the national suicide hotline number. Second, we expanded the campaign to also help individuals contemplating suicide, running the campaign for 19 days with a wider range of keywords through a co-designed website with a wider range of offerings (eg, lived experience stories)., Results: In the first study, the ad was shown 16,505 times and was clicked 664 times (4.02% click rate). There were 101 calls to the hotline. In the second study, the ad was shown 120,881 times and clicked 6227 times (5.15% click rate); of these 6227 clicks, there were 1419 (22.79%) engagements with the site, a substantially higher rate than the industry average of 3%. The number of clicks on the ad was high despite a suicide hotline banner likely being present., Conclusions: Search advertisements are a quick, far-reaching, and cost-efficient way of reaching those contemplating suicide and are needed despite suicide hotline banners being present., Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12623000084684; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385209., (©Sandersan Onie, Patrick Berlinquette, Sarah Holland, Nicola Livingstone, Coco Finemore, Nyree Gale, Emma Elder, George Laggis, Cassandra Heffernan, Susanne Oliver Armstrong, Adam Theobald, Natasha Josifovski, Michelle Torok, Fiona Shand, Mark Larsen. Originally published in JMIR Mental Health (https://mental.jmir.org), 20.04.2023.)

Background: Oral nicotine pouches (NPs) are smokeless, tobacco-free products that have a potential role in tobacco harm reduction strategies. Methods: In a cross-sectional study in Sweden/Denmark, several recognised biomarkers of potential harm (BoPHs) linked to smoking-related diseases/their initiating biological processes, and biomarkers of exposure (BoEs) to tobacco/tobacco smoke toxicants were compared among exclusive adult users of Velo NPs and current/former/never smokers. Over 24 h, participants used their usual product (Velo NP or cigarette) as normal, and BoEs/BoPHs were assessed via blood/24-h urine/exhaled breath/physiological assessments. Results: Among the primary endpoints, total NNAL (16.9 ± 29.47 vs 187.4 ± 228.93 pg/24 h), white blood cell count (5.59 ± 1.223 vs 6.90 ± 1.758 × 10 9 /L), and COHb (4.36 ± 0.525 vs 8.03 ± 2.173% saturation) were significantly lower among Velo users than among smokers (91%, 19% and 46% lower, respectively, all P  < 0.0001), while fractional exhaled NO, previously shown to be lower in smokers, was significantly higher (23.18 ± 17.909 vs 11.20 ± 6.980 ppb) among Velo users (107% higher, P  < 0.0001). Furthermore, sICAM-1 tended to be lower (185.9 ± 42.88 vs 204.5 ± 64.85 ng/mL) among Velo users than smokers (9% lower). Several secondary endpoints, including six BoEs (3-HPMA (246.7 ± 91.07 vs 1165.7 ± 718.35 μg/24 h), 3-OH-B[ a ]P (82.4 ± 217.58 vs 258.3 ± 190.20 pg/24 h), HMPMA (135.1 ± 77.85 vs 368.8 ± 183.15 μg/24 h), MHBMA (0.22 ± 0.166 vs 3.39 ± 2.943 μg/24 h), S-PMA (0.10 ± 0.059 vs 3.53 ± 2.736 µg/24 h) and total NNN (7.5 ± 24.84 vs 9.7 ± 5.93 ng/24 h)), were significantly lower among Velo users (78.8%, 68.1%, 63.4%, 93.5%, 97.2% and 22.7% lower, respectively, P  < 0.0001-0.0011), while total nicotine equivalents was significantly higher among Velo users (22.6 ± 12.69 vs 12.1 ± 7.92 mg/24 h, P  < 0.0001), although Velo user levels are comparable to those previously reported among oral tobacco users, and Velo user and smoker mean levels were similar in Denmark. Conclusion: As compared with smokers, exclusive users of Velo NPs have significantly less exposure to tobacco toxicants and more favourable BoPHs associated with initiating biological processes of smoking-related diseases.International Standard Registered Clinical Trial number: ISRCTN16988167.

Background: Diarrhoeal disease remains a significant cause of morbidity and mortality among the under-fives in many low- and middle-income countries. Changes to food safety practices and feeding methods around the weaning period, alongside improved nutrition, may significantly reduce the risk of disease and improve development for infants. We describe a protocol for a cluster randomised trial to evaluate the effectiveness of a multi-faceted community-based educational intervention that aims to improve food safety and hygiene behaviours and enhance child nutrition., Methods: We describe a mixed-methods, parallel group, two-arm, superiority cluster randomised controlled trial with baseline measures. One hundred twenty clusters comprising small urban and rural communities will be recruited in equal numbers and randomly allocated in a 1:1 ratio to either treatment or control arms. The community intervention will be focussed around an ideal mother concept involving all community members during campaign days with dramatic arts and pledging, and follow-up home visits. Participants will be mother-child dyads (27 per cluster period) with children aged 6 to 36 months. Data collection will comprise a day of observation and interviews with each participating mother-child pair and will take place at baseline and 4 and 15 months post-intervention. The primary analysis will estimate the effectiveness of the intervention on changes to complementary-food safety and preparation behaviours, food and water contamination, and diarrhoea. Secondary outcomes include maternal autonomy, enteric infection, nutrition, child anthropometry, and development scores. A additional structural equation analysis will be conducted to examine the causal relationships between the different outcomes. Qualitative and health economic analyses including process evaluation will be done., Conclusions: The trial will provide evidence on the effectiveness of community-based behavioural change interventions designed to reduce the burden of diarrhoeal disease in the under-fives and how effectiveness varies across different contexts., Trial Registration: ISRCTN14390796. Registration date December 13, 2021., (© 2023. The Author(s).)

Background: Lymphoedema is a chronic condition that is estimated to affect up to four people per 1000 of the UK population with this increasing with age. Men account for up to 20% of lymphoedema service caseloads with research focussing upon women affected., Aims: To retrieve primary qualitative research on the experiences of men with chronic lymphoedema., Methods: A qualitative review was undertaken using the Joanna Briggs Institute (JBI) meta-aggregation method. A search strategy was applied to 12 databases, from inception to February 2021, with 22 studies identified and appraised. The findings were extracted and synthesised via the JBI approach., Results: Four synthesised findings were identified: (1) The 'New Norm', how diagnosis led to men being faced with a 'new version' of themselves; (2) 'Journey into the Unknown' relates to the unforeseen diagnosis of the condition; (3) 'Access' - challenge in receiving a diagnosis, and support; and (4) 'Personhood' - the impact of the condition upon external constructs and relationships., Conclusions: Men are faced with similar challenges as women coupled with societal expectations with respect to gender identity and expression. This leads to those wishing to engage with men to adopt 'gender-based tailoring' within healthcare services, information and support., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2022.)

Background: Tobacco harm reduction (THR) aims to reduce the health burden of cigarettes by encouraging smokers to switch to using alternative tobacco or nicotine products. Nicotine pouches (NPs) are smokeless, tobacco-free, oral products that may be beneficial as part of a THR strategy., Objective: This 2-center, cross-sectional confinement study conducted in Denmark and Sweden aimed to determine whether biomarkers of exposure (BoEs) to tobacco toxicants and biomarkers of potential harm (BoPHs) in exclusive users of NPs show favorable differences compared with current smokers., Methods: Participants were healthy NP users (target n=100) and current, former, or never smokers (target n=40 each), as confirmed by urinary cotinine and exhaled carbon monoxide concentrations. During a 24-hour confinement period, participants were asked to use their usual product (NP or cigarette) as normal, and BoEs and BoPHs were measured in blood and 24-hour urine samples, with compliance determined using anabasine, anatabine, and N-(2-cyanoethyl)valine. BoEs and BoPHs were compared between NP users and current, former, and never smokers. Urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (BoE to nicotine-derived nitrosamine ketone) and urinary 8-epi-prostaglandin F2α type III, exhaled nitric oxide, blood carboxyhemoglobin, white blood cell count, soluble intercellular adhesion molecule-1, and high-density lipoprotein cholesterol (BoPHs) were evaluated as primary outcomes. Other measures included urinary 11-dehydrothromboxane B2, forced expiratory volume, carotid intima-media thickness, self-reported quality of life, and oral health., Results: The results of this study were received in mid-2022 and will be published in late 2022 to early 2023., Conclusions: The results of this study will provide information on toxicant exposure and biomarkers associated with the development of smoking-related diseases among users of NPs compared with smokers, as well as on the potential role of NPs in THR., Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN16988167; https://www.isrctn.com/ISRCTN16988167., International Registered Report Identifier (irrid): DERR1-10.2196/39785., (©David Azzopardi, Linsey Ellen Haswell, Justin Frosina, Michael McEwan, Nathan Gale, Jesse Thissen, Filimon Meichanetzidis, George Hardie. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 06.10.2022.)

The aim of this study was to investigate whether biomarkers of exposure (BoE) and potential harm (BoPH) are modified when smokers either continue to smoke or switch from smoking cigarettes to exclusive use of a tobacco heating product (THP) in an ambulatory setting over the period of a year, and to compare any changes with smokers who quit tobacco use completely and with never smokers' biomarker levels. Participants in this year-long ambulatory study were healthy smokers with a self-reported low intent to quit assigned either to continue smoking or switch to a THP; a group of smokers with a self-reported high intent to quit who abstained from tobacco use; and a group of never smokers. Various BoE and BoPH related to oxidative stress, cardiovascular and respiratory diseases and cancer were assessed at baseline and up to 360 days. Substantial and sustained reductions in BoE levels were found at 360 days for both participants who switched from smoking to THP use and participants who quit smoking, in many cases the reductions being of a similar order for both groups. The never smoker group typically had lower levels of the measured BoEs than either of these groups, and much lower levels than participants who continued to smoke. Several BoPHs were found to change in a favourable direction (towards never smoker levels) over the year study for participants who completely switched to THP or quit, while BoPHs such as soluble intercellular adhesion molecule-1 were found to change in an unfavourable direction (away from never smoker levels) in participants who continued to smoke. Our findings, alongside chemical and toxicological studies undertaken on the THP used in this study, lead to the conclusion that smokers who would have otherwise continued to smoke and instead switch entirely to the use of this THP, will reduce their exposure to tobacco smoke toxicants and as a consequence are reasonably likely to reduce disease risks compared to those continuing to smoke., (© 2022. The Author(s).)

Introduction: The significance of the role of receptionists during the recent shift to remote triage has been widely recognised and they will have a significant role to play in UK general practice as it continues to cope with a huge increase in demand exacerbated by the COVID-19 pandemic. To maximise their contribution, it is important the social and occupational characteristics of the modern receptionist are understood, alongside their attitudes towards the role and their perceptions of the support and training they receive ., Methods: We used convenience and cross-sectional sampling to survey the demographic characteristics of receptionists and various aspects of their role and responsibilities. This included the training received, specific tasks performed, job satisfaction, the importance of the role, and their interaction with clinical and non-clinical colleagues. We also captured data on the characteristics of their practice including the number of GPs and location., Results: A total of 70 participants completed the survey (16 postal and 54 online responses) of whom the majority were white (97.2%), female (98.6%), and aged 40 and over (56.7%). The majority of the training focussed on customer service (72.9%), telephone (64.3%), and medical administration skills (58.6%). Just over a quarter had received training in basic triage (25.7%). A standard multiple regression model revealed that the strongest predictor of satisfaction was support from practice GPs (β = .65, p <.001) there were also significant positive correlations between satisfaction and appreciation from GPs, r(68) = .609, p < .001., Conclusion: This study has provided a much-needed update on the demographics, duties, and job satisfaction of GP receptionists. The need for diversification of the workforce to reflect the range of primary care patients warrants consideration in light of continuing variation in access along lines of gender andethnicity. Training continues to focus on administrative duties not on the clinically relevant aspects of their role such as triage., (© 2022. The Author(s).)

Tobacco heating products (THPs) have reduced emissions of toxicants compared with cigarette smoke, and as they expose user to lower levels than smoking, have for a role to play in tobacco harm reduction. One key concern of Public Health is that new tobacco and nicotine products should not be more addictive than cigarettes. To assess their abuse liability, we determined nicotine pharmacokinetics and subjective effects of two THPs compared with conventional cigarettes and a nicotine replacement therapy (Nicotine inhaler). In a randomised, controlled, open-label, crossover study healthy adult smokers used a different study product in a 5 min ad libitum use session in each of four study periods. Product liking, overall intent to use again, urge for product and urge to smoke questionnaires were utilised to assess subjective effects. Nicotine uptake was greater for the cigarette (C max  = 22.7 ng/mL) than for either THP (8.6 and 10.5 ng/mL) and the NRT (2.3 ng/mL). Median T max was significantly longer for the NRT (15.03 min) than for the tobacco products (4.05-6.03 min). Product liking and overall intent to use again was highest for the cigarette, and higher for the THPs than the NRT. Urge to smoke was reduced more by the cigarette than by the other three products. Urge to use the THPs was greater than the NRT. These findings suggest that the abuse liability of the THPs lies between that of subjects usual brand cigarettes and the NRT., (© 2022. The Author(s).)

The effect of metabolic syndrome (MetS) and clusters of its components on central blood pressure (CBP) has not been well characterized. We aimed to describe the effect of MetS and clusters of its components on CBP in a large population and to identify whether this effect differs in men and women. We studied 15,609 volunteers (43% women) from 10 cohorts worldwide who participated in the Metabolic syndrome and Artery REsearch Consortium. MetS was defined according to the NCEP-ATP III criteria (GHTBW, glucose, high-density lipoprotein cholesterol, triglyceride, blood pressure, waist circumference). CBP was measured noninvasively and acquired from pulse wave analysis by applanation tonometry. MetS was associated with a 50% greater odds of having higher CSBP. After controlling for age, male sex, non HDL cholesterol, diabetes mellitus, and mean arterial pressure, only specific clusters of MetS components were associated with a higher CSBP; and some of them were significant in women but not in men. We identified "risky clusters" of MetS variables associated with high CSBP. Future studies are needed to confirm they identify subjects at high risk of accelerated arterial aging and, thus, need more intensive clinical management., (© 2022. The Author(s).)

COPD is increasingly common in China but is poorly understood by patients, medications are not used as prescribed and there is no access to recommended non-pharmacological treatment. We explored COPD patients' and general practitioners' (GPs) knowledge of COPD, views on its management and the acceptability of a flexible lung health service (LHS) offering health education, exercise, self-management, smoking cessation and mental health support. Using a convergent mixed methods design, data were collected from patients and GPs using focus groups (FGs) in four Chinese cities, questionnaires were also used to collect data from patients. FGs were audio-recorded and transcribed. Quantitative data were analysed descriptively, thematic framework analysis was used for the qualitative data. Two-hundred fifty-one patients completed the questionnaire; 39 patients and 30 GPs participated in ten separate FGs. Three overarching themes were identified: patients' lack of knowledge/understanding of COPD, current management of COPD not meeting patients' needs and LHS design, which was well received by patients and GPs. Participants wanted COPD education, TaiChi, psychological support and WeChat for social support. 39% of survey responders did not know what to do when their breathing worsened and 24% did not know how to use their inhalers. 36% of survey respondents requested guided relaxation. Overall, participants did not fully understand the implications of COPD and current treatment was sub-optimal. There was support for developing a culturally appropriate intervention meeting Chinese patients' needs, health beliefs, and local healthcare delivery. Further research should explore the feasibility of such a service., (© 2022. The Author(s).)

Background: Tobacco Heating Products (THPs) are tobacco products that heat rather than burn tobacco with temperatures less than 350 °C. Because of this operating principle, they produce substantially fewer and lower levels of tobacco smoke toxicants than combustible cigarette smoke produced when tobacco is burnt, which occurs at much higher temperatures of around 900 °C. This paper analyses data on a THP, glo™, and assesses whether its use would result in reduced health risks compared to the health risks of smoking cigarettes. It also looks at the possibility of bridging datasets across the different variants of the glo™ product., Methods: The approach is to consider whether datasets from behavioural, chemical, toxicological and clinical studies provide consistent findings of reductions in toxicant exposure with glo™ use by subjects who switch completely from smoking cigarettes to using glo™ and whether these reductions are similar to those who stop smoking cigarettes without switching to glo™ or any other tobacco or nicotine product. We also examine the similarities and differences of different versions of the glo™ product and benchmark it against a THP from another manufacturer., Results: The studies indicate that the use of the glo™ results in substantial and prolonged reductions in toxicant exposure for smokers who switch to glo™ completely. A long-term clinical study shows substantial reductions in toxicant exposure over a period of time, similar to reduction of some biomarkers of exposure found following smoking cessation without switching to glo™ or any other tobacco product, and biomarkers of potential harm trending in a favourable manner for both groups that switch to glo™ and that quit all tobacco and nicotine use. Data suggests that all iterations of glo™ result in substantial reductions in toxicant exposure compared to smoking cigarettes and that bridging across datasets is feasible., Conclusions: Given the accumulated scientific data summarised in this paper, and particularly the findings from a long-term clinical study, the data demonstrate that glo™ is a reduced exposure product compared to combustible cigarettes and is reasonably deemed to reduce the risk of smoking-related diseases and supports the conclusion that smokers who would have otherwise continued to smoke and instead switch entirely to THP glo™ use, will reduce their relative risk of developing smoking-related diseases as compared to continued smoking. The extent of reduction in risk compared to continuing to smoke is likely to vary by smoking-related disease and by an individuals' smoking history, other risk factors and an individual's susceptibility to disease. Use of the THP will present some level of increased health risk as compared to cessation of tobacco and nicotine products and will cause dependence. As long as the principles of heat-not-burn are maintained, THP use will result in substantially reduced exposure to smoke toxicants as compared to continued conventional cigarette smoking. It is possible to use bridging or read across to apply these conclusions to new iterations of the glo™ product, extending the utility and validity of the evidence generated through study of prior iterations., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: SG, NG, DT, SH, KP, IG, and FM were employees of a tobacco and nicotine product manufacturer, British American Tobacco (Investments) Limited at the time the studies were conducted. CP is a former employee of British American Tobacco (Investments) Limited and contributed as a paid consultant to British American Tobacco (Investments) Limited., (© 2022 The Authors.)

In this article, we review the chapter on tumors of the larynx, hypopharynx, trachea and parapharyngeal space in the new edition of the WHO book, focusing on the new developments in comparison to the previous edition. Squamous cell carcinoma (SCC) and its variants are by far the most common malignancies at these locations, with very limited new insights. The most important is the introduction of new targeted treatment-checkpoint inhibitors, with a new task for pathologists, who may help to predict the response to treatment by analyzing the expression of targeted proteins in biopsy samples. Precancerous lesions remain a controversial topic and, similarly to other organs, it is acceptable to use the terms "dysplasia" or "squamous intraepithelial lesion" (SIL), but there is a slight difference between low-grade dysplasia and low-grade SIL: in the former, mild atypia must be present, while the latter also includes hyperplastic epithelium without atypia. Two approaches have been proposed: a two-tiered system with low- and high-grade dysplasia/SIL and a three-tiered system with an additional category, carcinoma in situ. We are still searching for reliable diagnostic markers to surpass the subjectivity in biopsy diagnosis, with a few potential candidate markers on the horizon, e.g., stem cell markers. Other tumors are rare at these locations, e.g., hematolymphoid, neuroendocrine and salivary gland neoplasms, and are no longer included in Chapter 3. They must be diagnosed according to criteria described in specific chapters. The same holds true for soft tissue tumors, with the exception of cartilaginous neoplasms, which are still included in Chapter 3., (© 2022. The Author(s).)

Background and Objectives: Nicotine pouches (NPs) are a relatively new type of oral smokeless tobacco-free nicotine product. Currently, few data are available on the nicotine pharmacokinetics or subjective effects of NP use. The objective of this study was to determine and compare the pharmacokinetics of nicotine absorption into the blood from different NP variants and a combustible cigarette., Methods: In a randomised, controlled, crossover clinical study, nicotine pharmacokinetics and subjective effects were compared among commercially available NPs (five different brands; 6-10 mg nicotine/pouch) and a combustible cigarette. During an 8-day confinement period, 35 healthy adult participants who were current dual users of snus and combustible cigarettes used one study product each day for a defined period following overnight nicotine abstinence., Results: Nicotine maximum plasma concentration (C max ) and area under the plasma concentration-time curve between 0 and 6 h (AUC 0-6h ) were significantly greater for the Lyft 10 mg NP than for the cigarette (both p < 0.0001), while the other NPs had C max and AUC 0-6h values that were either greater than or similar to those of the cigarette. Plasma nicotine concentration was not associated with the nicotine contents of the NPs. Time to reach maximum plasma concentration (T max ) was higher for all NPs (60-65 min) than for the cigarette (7 min). Regarding subjective effects, liking and intent to use product again scores were higher for the cigarette than for any NP and were lowest for the NP with the lowest nicotine content., Conclusions: This study provides important insight into nicotine pharmacokinetics and subjective effects during NP use, and demonstrates that NPs can provide nicotine in amounts sufficient to replicate cigarette smokers' nicotine uptake following a switch from conventional cigarettes to these potentially less harmful NP products. Further studies are required to ascertain how physical characteristics of NPs other than nicotine content may affect nicotine delivery, pharmacokinetics and subjective responses., Isrctn Clinical Trial Registry: ISRCTN17828518., (© 2021. The Author(s).)

Lysosomal diseases are a class of genetic disorders predominantly caused by loss of lysosomal hydrolases, leading to lysosomal and cellular dysfunction. Enzyme replacement therapy (ERT), where recombinant enzyme is given intravenously, internalized by cells, and trafficked to the lysosome, has been applied to treat several lysosomal diseases. However, current ERT regimens do not correct disease phenotypes in all affected organs because the biodistribution of enzyme uptake does not match that of the affected cells that require the enzyme. We present here targeted ERT, an approach that utilizes antibody-enzyme fusion proteins to target the enzyme to specific cell types. The antibody moiety recognizes transmembrane proteins involved in lysosomal trafficking and that are also preferentially expressed in those cells most affected in disease. Using Pompe disease (PD) as an example, we show that targeted ERT is superior to ERT in treating the skeletal muscle phenotypes of PD mice both as a protein replacement therapeutic and as a gene therapy., Competing Interests: Declaration of interests All authors were employees of Regeneron Pharmaceuticals, Inc., while engaged in the study and may hold stock and/or stock options in the company. A.D.B. and K.D.C. have patent applications for internalizing enzymes and uses thereof., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

The aim of this study was to investigate whether biomarkers of exposure (BoE) and potential harm (BoPH) are modified when smokers switch from smoking cigarettes to exclusive use of a tobacco heating product (THP) in an ambulatory setting. Participants in this randomised, controlled study were healthy volunteer smokers assigned either to continue smoking or switch to a THP, and a control group of smokers who abstained from cigarette smoking. Various BoE and BoPH related to oxidative stress, cardiovascular and respiratory diseases, and cancer were assessed at baseline and up to 180 days. In continuing smokers, BoE and BoPH remained stable between baseline and day 180, while THP users' levels of most BoE reduced significantly, becoming similar to those in controls abstaining from cigarette smoking. Also at 180 days, significant changes in numerous BoPH, including total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, 8-epi-prostaglandin F2α type III, fractional concentration of exhaled nitric oxide and white blood cell count, were directionally consistent with lessened health impact. Our findings support the notion that the deleterious health impacts of cigarette smoking may be reduced in smokers who completely switch to using THPs., (© 2021. The Author(s).)