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BACKGROUND: Despite disproportionate rates of mental ill-health compared with non-Indigenous populations, few programs have been tailored to the unique health, social, and cultural needs and preferences of young Aboriginal and Torres Strait Islander males. This paper describes the process of culturally adapting the US-based Young Black Men, Masculinities, and Mental Health (YBMen) Project to suit the needs, preferences, culture, and circumstances of Aboriginal and Torres Strait Islander males aged 16-25 years in the Northern Territory, Australia. YBMen is an evidence-based social media-based education and support program designed to promote mental health, expand understandings of gender and cultural identities, and enhance social support in college-aged Black men. METHODS: Our adaptation followed an Extended Stages of Cultural Adaptation model. First, we established a rationale for adaptation that included assessing the appropriateness of YBMen's core components for the target population. We then investigated important and appropriate models to underpin the adapted program and conducted a non-linear, iterative process of gathering information from key sources, including young Aboriginal and Torres Strait Islander males, to inform program curriculum and delivery. RESULTS: To maintain program fidelity, we retained the core curriculum components of mental health, healthy masculinities, and social connection and kept the small cohort, private social media group delivery but developed two models: 'online only' (the original online delivery format) and 'hybrid in-person/online' (combining online delivery with weekly in-person group sessions). Adaptations made included using an overarching Aboriginal and Torres Strait Islander social and emotional wellbeing framework and socio-cultural strengths-based approach; inclusion of modules on health and wellbeing, positive Indigenous masculinities, and respectful relationships; use of Indigenous designs and colours; and prominent placement of images of Aboriginal and Torres Strait Islander male sportspeople, musicians, activists, and local role models. CONCLUSIONS: This process resulted in a culturally responsive mental health, masculinities, and social support health promotion program for young Aboriginal and Torres Strait Islander males. Next steps will involve pilot testing to investigate the adapted program's acceptability and feasibility and inform further refinement.
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Saúde Mental , Havaiano Nativo ou Outro Ilhéu do Pacífico , Apoio Social , Humanos , Masculino , Havaiano Nativo ou Outro Ilhéu do Pacífico/psicologia , Adolescente , Adulto Jovem , Adulto , Northern Territory , Estados Unidos , Mídias Sociais , Povos Aborígenes Australianos e Ilhéus do Estreito de TorresRESUMO
BACKGROUND: Previous studies identified corrosion between the modular tibial components of total knee arthroplasty (TKA) devices. In this study, we investigated the damage modes present in titanium-titanium (Ti-Ti) junctions in the knee. We asked: under typical in vivo cyclic loading conditions, will the same alloy damage modes from TKA devices resemble those documented in the hip? METHODS: A total of 50 paired titanium alloy tibial baseplates and stems were collected and semi-quantitatively analyzed using Goldberg corrosion scoring. To characterize damage, a subsection of moderately and severely corroded components was sectioned and imaged using scanning electron and digital optical microscopy. RESULTS: Of the 100 device components, 95% showed visual evidence of corrosion. The initial contact area between the stem and bore generally occurred 3 mm from the stem taper base. Scanning electron microscopy revealed four damage modes, including oxide film formation, crevice corrosion, selective dissolution, and pitting. CONCLUSIONS: Each of the damage modes identified in modular Ti-Ti tibial junctions was previously reported by total hip arthroplasty retrieval studies. Cumulatively, our results suggest that mechanically assisted crevice corrosion promoted this damage in vivo.
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AIMS: This article explores the crucial role of 'place' as an ecological, social and cultural determinant of health and well-being, with a focus on the benefits and challenges of living rurally and remotely in Australia. CONTEXT: The health system, including health promotion, can contribute actively to creating supportive environments and places that foster health and well-being among individuals residing in rural and remote locations. For First Nations peoples, living on Country, and caring for Country and its people, are core to Indigenous worldviews, and the promotion of Aboriginal and Torres Strait Islander health and well-being. Their forced removal from ancestral lands has been catastrophic. For all people, living in rural and remote areas can deliver an abundance of the elements that contribute to a 'liveable' community, including access to fresh air, green and blue space, agricultural employment, tight-knit communities, a sense of belonging and identity, and social capital. However, living remotely also can limit access to employment opportunities, clean water, affordable food, reliable transport, social infrastructure, social networks and preventive health services. 'Place' is a critical enabler of maintaining a healthy life. However, current trends have led to a reduction in local services and resources, and increased exposure to the impacts of climate change. APPROACH: This commentary suggests ideas and strategies through which people in rural and remote locations can strengthen the liveability, resilience and identity of their communities, and regain access to essential health care and health promotion services and resources. CONCLUSION: Recommended strategies include online access to education, employment and telehealth; flexible provision of social infrastructure; and meaningful and responsive university-health service partnerships.
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Ultra-high-molecular-weight polyethylene (UHMWPE) components for orthopedic implants have historically been integrated into metal backings by direct-compression molding (DCM). However, metal backings are costly, stiffer than cortical bone, and may be associated with medical imaging distortion and metal release. Hybrid-manufactured DCM UHMWPE overmolded additively manufactured polyetheretherketone (PEEK) structural components could offer an alternative solution, but are yet to be explored. In this study, five different porous topologies (grid, triangular, honeycomb, octahedral, and gyroid) and three surface feature sizes (low, medium, and high) were implemented into the top surface of digital cylindrical specimens prior to being 3D printed in PEEK and then overmolded with UHMWPE. Separation forces were recorded as 1.97-3.86 kN, therefore matching and bettering the historical industry values (2-3 kN) recorded for DCM UHMWPE metal components. Infill topology affected failure mechanism (Type 1 or 2) and obtained separation forces, with shapes having greater sidewall numbers (honeycomb-60%) and interconnectivity (gyroid-30%) through their builds, tolerating higher transmitted forces. Surface feature size also had an impact on applied load, whereby those with low infill-%s generally recorded lower levels of performance vs. medium and high infill strategies. These preliminary findings suggest that hybrid-manufactured structural composites could replace metal backings and produce orthopedic implants with high-performing polymer-polymer interfaces.
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Gender-responsive healthcare is critical to advancing men's health given that masculinities intersect with other social determinants to impact help-seeking, engagement with primary healthcare, and patient outcomes. A scoping review was undertaken with the aim to synthesize gender-responsive approaches used by healthcare providers (HCPs) to engage men with primary healthcare. MEDLINE, PubMed, CINAHL, and PsycINFO databases were searched for articles published between 2000 and February 2024. Titles and abstracts for 15,659 citations were reviewed, and 97 articles met the inclusion criteria. Data were extracted and analyzed thematically. Thirty-three approaches were synthesized from across counseling/psychology, general practice, social work, nursing, psychiatry, pharmacy, and unspecified primary healthcare settings. These were organized into three interrelated themes: (a) tailoring communication to reach men; (b) purposefully structuring treatment to meet men's health needs, and (c) centering the therapeutic alliance to retain men in care. Strength-based and asset-building approaches focused on reading and responding to a diversity of masculinities was reinforced across the three findings. While these approaches are recommended for the judicious integration into health practitioner education and practice, this review highlighted that the evidence remains underdeveloped, particularly for men who experience health inequities. Critical priorities for further research include intersectional considerations and operationalizing gender-responsive healthcare approaches for men and its outcomes, particularly at first point-of-contact encounters.
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Masculinidade , Saúde do Homem , Masculino , Humanos , Comunicação , Pessoal de Saúde , Atenção Primária à SaúdeRESUMO
BACKGROUND: During 2017-18, the Northern Territory (NT) introduced a Banned Drinker Register (BDR) and Minimum Unit Price (MUP) NT-wide; Police Auxiliary Liquor Inspectors (PALIs) in three regional towns; and restrictions on daily purchases/opening hours (DPOH) in one regional town. The BDR is an individual-level alcohol ban; MUP is a pricing policy; and PALIs enforce bans on restricted areas at takeaway outlets. This study examines the impact of these policies on adult domestic and family violence (DFV). METHODS: We examined DFV assaults and breaches of violence orders from January 2014 - February 2020 using interrupted time series models for NT, Greater Darwin, Katherine, Tennant Creek, and Alice Springs. To account for increasing numbers of individuals on the BDR we tested two timepoints (Sept 2017, March 2018). FINDINGS: Following DPOH, assaults (78 %) and alcohol-involved assaults (92 %) decreased in Tennant Creek. After PALIs, assaults (79 %) in Tennant Creek, and breaches (39 %) and alcohol-involved breaches (58 %) in Katherine decreased. After MUP, assaults (11 %), alcohol-involved assaults (21 %) and alcohol-involved breaches (21%) decreased NT wide. After MUP/PALIs in Alice Springs, alcohol-involved assaults (33 %), breaches (42 %), and alcohol-involved breaches (57 %) decreased. BDR (Sept 2017) found increases in assaults (44 %) and alcohol-involved assaults (39 %) in Katherine and assaults (10%) and alcohol-involved assaults NT-wide (17 %). There were increases of 21 %-45 % in breaches NT-wide, in Darwin, Katherine, and Alice Springs. Following March 2018 found increases in assaults (33 %) and alcohol-involved assaults (48 %) in Katherine. There were increases - from 20 % to 56 % - in breaches in NT-wide, Katherine, and Alice Springs. CONCLUSION: PALIs and DPOH were associated with some reductions in DFV; the BDR was associated with some increases. The upward trend commences prior to the BDR, so it is also plausible that the BDR had no effect on DFV outcomes. Although MUP was associated with reductions in the NT-wide model, there were no changes in sites without cooccurring PALIs.
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Consumo de Bebidas Alcoólicas , Bebidas Alcoólicas , Violência Doméstica , Polícia , Humanos , Northern Territory/epidemiologia , Consumo de Bebidas Alcoólicas/epidemiologia , Bebidas Alcoólicas/provisão & distribuição , Bebidas Alcoólicas/economia , Adulto , Violência Doméstica/estatística & dados numéricos , Feminino , Comércio/estatística & dados numéricos , Comércio/legislação & jurisprudência , Masculino , Análise de Séries Temporais InterrompidaRESUMO
Today, relatively warm Circumpolar Deep Water is melting Thwaites Glacier at the base of its ice shelf and at the grounding zone, contributing to significant ice retreat. Accelerating ice loss has been observed since the 1970s; however, it is unclear when this phase of significant melting initiated. We analyzed the marine sedimentary record to reconstruct Thwaites Glacier's history from the early Holocene to present. Marine geophysical surveys were carried out along the floating ice-shelf margin to identify core locations from various geomorphic settings. We use sedimentological data and physical properties to define sedimentary facies at seven core sites. Glaciomarine sediment deposits reveal that the grounded ice in the Amundsen Sea Embayment had already retreated to within ~45 km of the modern grounding zone prior to ca. 9,400 y ago. Sediments deposited within the past 100+ y record abrupt changes in environmental conditions. On seafloor highs, these shifts document ice-shelf thinning initiating at least as early as the 1940s. Sediments recovered from deep basins reflect a transition from ice proximal to slightly more distal conditions, suggesting ongoing grounding-zone retreat since the 1950s. The timing of ice-shelf unpinning from the seafloor for Thwaites Glacier coincides with similar records from neighboring Pine Island Glacier. Our work provides robust new evidence that glacier retreat in the Amundsen Sea was initiated in the mid-twentieth century, likely associated with climate variability.
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Polychlorinated dibenzo-p-dioxins and furans (PCDD/Fs) and dioxin-like polychlorinated biphenyls (dl-PCBs) are a suite of harmful chemicals (hereafter collectively referred to as 'dioxins'), and their emission into aquatic habitats leads to persistent contamination of sediments, aquatic food-webs, and seafoods. Quantifying contaminant levels in seafood species is important for the ongoing management of exposure risk by fishers, particularly after any remediation actions. We present dioxin concentrations in four seafood species (Yellowfin Bream Acanthopagrus australis, Sea Mullet Mugil cephalus, Eastern School Prawn Metapenaeus macleayi, and Eastern King Prawn Penaeus plebejus) in a recreationally fished estuary, in relation to a contaminated site that has undergone a remediation process, partially removing contaminated sediments (Homebush Bay, Port Jackson, New South Wales, Australia). Dioxin concentrations in these species were measured before (2005/6) and after (2015/16) remediation at a range of locations in and around the remediated site. Dioxin concentrations and congener profiles differed substantially among taxa, and concentrations were frequently higher than Australian screening criteria. The two prawn species showed evidence of a decline in dioxin concentrations after remediation, but the fish species only showed a declining dioxin concentration with distance from the contaminated site (not between periods). There were some minor changes in the congener profile for some species following remediation. While there was evidence for greatly reduced dioxin concentrations in prawn species following remediation, the complex patterns for fish were likely affected by environmental changes, species-specific and temporal changes in lipid content, and animal movement patterns. Future monitoring may aid interpretation of the patterns and modelling of exposure risk associated with seafood consumption into the future.
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Decápodes , Dioxinas , Bifenilos Policlorados , Dibenzodioxinas Policloradas , Animais , Dibenzodioxinas Policloradas/análise , Dioxinas/análise , Bifenilos Policlorados/análise , Estuários , Furanos , Dibenzofuranos , Austrália , Crustáceos , Dibenzofuranos Policlorados/análiseRESUMO
INTRODUCTION: Between 2017 and 2018 three major alcohol policy changes were introduced in the Northern Territory (NT): the Banned Drinker Register, an individual-level ban enforced via ID scanners at takeaway outlets; a Minimum Unit Price on alcohol; and Police Auxiliary Liquor Inspectors, who monitor takeaway outlets to prevent purchase by people who do not have a legal place to consume alcohol. We aimed to: (i) describe alcohol-involved adult sexual assault in the NT; and (ii) estimate the impacts of these alcohol policies on police-recorded adult sexual assault. METHODS: We used victim records for sexual assault where victims were aged 15 years and over. We undertook descriptive analyses for the NT from 2014 to 2020 and used interrupted time series analysis to assess policy impacts across the NT and in Greater Darwin. RESULTS: In 2020, the NT adult victimisation rate was 105 per 100,000. A large minority (40%) of adult sexual assaults involved alcohol. Interrupted time series analyses showed no effect of the Banned Drinker Register or Minimum Unit Price on sexual assault across the NT or in Greater Darwin. DISCUSSION AND CONCLUSIONS: The rate of adult sexual assaults in the NT is extremely high and many involve alcohol. Neither the Banned Drinker Register or Minimum Unit Price were associated with changes in police-recorded adult sexual assault in Greater Darwin or across the NT. Due to small counts, we were unable to assess policy impacts in three of the four main towns, highlighting the challenges of assessing impacts of policies on sexual assault in small population areas.
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Vítimas de Crime , Delitos Sexuais , Adulto , Humanos , Polícia , Northern Territory/epidemiologia , Etanol , Política Pública , Delitos Sexuais/prevenção & controleRESUMO
BACKGROUND: Young males experience markedly poorer mental health outcomes. Organised sport settings provide novel prospects to improve the mental health of this subpopulation. AIM: This systematic review aimed to evaluate interventions targeted at the promotion of mental health and wellbeing among young males in organised sporting contexts. METHODS: Six databases (SportDiscus, PsycInfo, Medline, Web of Science, Scopus, CINAHL) were searched from inception to June 2022 (and updated in September 2023). Eligible studies examined interventions targeting the mental health and wellbeing (e.g., depression, anxiety, resilience) or mental health literacy (e.g., stigmatising attitudes, help-seeking) of young males aged 10-24 years (or associated stakeholder samples; e.g., parents or coaches of male youth). RESULTS: A total of 15 studies were included in this review. Overall, the findings indicate promising effects of sport-based interventions on the mental health and mental health literacy outcomes of young males. CONCLUSIONS: This review suggests that there is scope to improve the capacity of sports-based interventions to affect positive change in the mental health of male youth. The findings from this review also have important implications for the development and evaluation of sports-based interventions targeted at young males in future.
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Letramento em Saúde , Esportes , Adolescente , Masculino , Humanos , Saúde Mental , Esportes/psicologia , Ansiedade , Transtornos de AnsiedadeRESUMO
Online mental health interventions have received attention for their potential to bypass barriers that stop men from seeking mental health help from a health professional. However, emerging data suggest that men's use of online mental health interventions is low, and when used, early attrition is common. In this commentary, we hypothesise that men's common lack of engagement with online mental health interventions may reflect limited attention being paid to the needs and preferences of potential users during their development. We outline a series of considerations that we believe are important to advance the development of acceptable, effective online mental health interventions for men: (1) men's diverse and intersecting characteristics, circumstances, and needs; (2) centring positive, progressive masculinities; and (3) listening to, learning from, and working in partnership with men to develop interventions. We also examine how existing online mental health interventions targeting men have engaged with these considerations. Keywords: men, male, mental health, e-mental health, digital health, online interventions.
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Intervenção Baseada em Internet , Saúde Mental , Masculino , Humanos , Saúde do Homem , Homens/psicologia , MasculinidadeRESUMO
BACKGROUND: Little is known about men's use of online mental health (eMH) interventions and factors that promote their engagement or attrition. We aimed to synthesise the qualitative literature on men's preferences for, attitudes towards, and experiences of using eMH interventions for depression and anxiety, and develop recommendations from the findings. METHOD: Systematic searches were conducted (Jan 2000-Oct 2020) in six databases; study quality was assessed using Qualsyst with a minimum total of 0.55 required for inclusion. Extracted data were synthesised using meta-aggregation. RESULTS: Eight studies met inclusion criteria and three synthesised findings were generated. (1) Facilitators of men's eMH use: finding apps and technology motivating and convenient, support and encouragement from important others, and interventions allowing men to take action, gain control over their mental health, and resulting in positive outcomes; (2) Barriers to men's eMH use: lack of free time, predicted or experienced lack of benefit from use, and technical difficulties; (3) What men want in eMH: personalised, tailored, relevant interventions that are bright and easy to use, with information presented in multiple formats, psychoeducation, exercises, self-monitoring, information on further resources, and the option of clinician involvement, without any repetitive questioning, boring tools, or negative feedback. LIMITATIONS: All included studies were conducted in high income, 'Western' countries; most data related to experiences of using an existing eMH intervention within a trial, rather than in 'real world' settings where eMH acceptability is generally lower and experiences may differ. CONCLUSIONS: Practice, research, and policy recommendations are presented.
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Depressão , Saúde Mental , Masculino , Humanos , Depressão/terapia , Ansiedade/terapia , Transtornos de Ansiedade/terapia , AtitudeRESUMO
Purpose: The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force of the EU Medical Device Regulation in May 2021. Methods: We systematically reviewed the medical literature for a random selection of hip and knee implants to identify all peer-reviewed clinical investigations published within 10 years before and up to 20 years after regulatory approval. We report study characteristics, methodologies, outcomes, measures to prevent bias, and timing of clinical investigations of 30 current implants. The review process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: We identified 2912 publications and finally included 151 papers published between 1995 and 2021 (63 on hip stems, 34 on hip cups, and 54 on knee systems). We identified no clinical studies published before Conformité Européene (CE)-marking for any selected device, and no studies even up to 20 years after CE-marking in one-quarter of devices. There were very few randomized controlled trials, and registry-based studies generally had larger sample sizes and better methodology. Conclusion: The peer-reviewed literature alone is insufficient as a source of clinical investigations of these high-risk devices intended for life-long use. A more systematic, efficient, and faster way to evaluate safety and performance is necessary. Using a phased introduction approach, nesting comparative studies of observational and experimental design in existing registries, increasing the use of benefit measures, and accelerating surrogate outcomes research will help to minimize risks and maximize benefits.
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Although highly related, mental illness may not fully determine perceived well-being, a distinction captured by dual-continuum models. Separating mental illness and well-being into related but separate constructs prompted investigation into potential buffers to reduce the impact of mental illness on perceived well-being. This study explored two such buffers in health literacy and psychological resilience among Australian men. Using the Ten to Men Australian Longitudinal Study on Male Health, this secondary data analysis of n = 8,408 men between 18 and 60 years of age assessed the moderating effect of three components of health literacy (feeling supported by health care providers, ability to find health information, and active engagement with health care providers) and psychological resilience on the relationship between mental illness and well-being. Mental illness symptoms were negatively associated with well-being, whereas psychological resilience, active engagement with health care, and health care provider support (ß res = .65, ß eng = .28, and ß sup = .25) had positive significant relationships with the outcome (all p ≤ .001). Ability to find health information (p = .25) and psychological resilience (p = .43) were not significantly associated with well-being. Of the four interactions tested, health literacy relating to health care worker support was the only significant moderator between mental illness and well-being (ß sup = .03). This study identified that meaningful support and understanding from health care providers for Australian men aged between 18 and 60 years may somewhat ameliorate the impact of mental illness on well-being. Further related investigation may reveal specific interventions that improve perceptions of support among men.
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Letramento em Saúde , Transtornos Mentais , Resiliência Psicológica , Masculino , Humanos , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Estudos Longitudinais , AustráliaRESUMO
INTRODUCTION: Improving physical activity (PA) and healthy eating is critical for primary and secondary prevention of cardiovascular disease (CVD). Behaviour change programmes delivered in sporting clubs can engage men in health behaviour change, but are rarely sustained or scaled-up post trial. Following the success of pilot studies of the Australian Fans in Training (Aussie-FIT) programme, a hybrid effectiveness-implementation trial protocol was developed. This protocol outlines methods to: (1) establish if Aussie-FIT is effective at supporting men with or at risk of CVD to sustain improvements in moderate-to-vigorous PA (primary outcome), diet and physical and psychological health and (2) examine the feasibility and utility of implementation strategies to support programme adoption, implementation and sustainment. METHODS AND ANALYSIS: A pragmatic multistate/territory hybrid type 2 effectiveness-implementation parallel group randomised controlled trial with a 6-month wait list control arm in Australia. 320 men aged 35-75 years with or at risk of CVD will be recruited. Aussie-FIT involves 12 weekly face-to-face sessions including coach-led interactive education workshops and PA delivered in Australian Football League (Western Australia, Northern Territory) and rugby (Queensland) sports club settings. Follow-up measures will be at 3 and 6 months (both groups) and at 12 months to assess maintenance (intervention group only). Implementation outcomes will be reported using the Reach, Effectiveness, Adoption, Implementation, Maintenance framework. ETHICS AND DISSEMINATION: This multisite study has been approved by the lead ethics committees in the lead site's jurisdiction, the South Metropolitan Health Service Human Research Ethics Committee (Reference RGS4254) and the West Australian Aboriginal Health Ethics Committee (HREC1221). Findings will be disseminated at academic conferences, peer-reviewed journals and via presentations and reports to stakeholders, including consumers. Findings will inform a blueprint to support the sustainment and scale-up of Aussie-FIT across diverse Australian settings and populations to benefit men's health. TRIAL REGISTRATION NUMBER: This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623000437662).
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Doenças Cardiovasculares , Comportamentos Relacionados com a Saúde , Promoção da Saúde , Saúde do Homem , Humanos , Masculino , Doenças Cardiovasculares/prevenção & controle , Serviços de Saúde do Indígena , Northern Territory , Ensaios Clínicos Controlados Aleatórios como Assunto , Esportes de Equipe , Adulto , Pessoa de Meia-Idade , Idoso , AustráliaRESUMO
Neuraminidases cleave sialic acids from glycocalyx structures and plasma neuraminidase activity is elevated in type 2 diabetes (T2D). Therefore, we hypothesize circulating neuraminidase degrades the endothelial glycocalyx and diminishes flow-mediated dilation (FMD), whereas its inhibition restores shear mechanosensation and endothelial function in T2D settings. We found that compared with controls, subjects with T2D have higher plasma neuraminidase activity, reduced plasma nitrite concentrations, and diminished FMD. Ex vivo and in vivo neuraminidase exposure diminished FMD and reduced endothelial glycocalyx presence in mouse arteries. In cultured endothelial cells, neuraminidase reduced glycocalyx coverage. Inhalation of the neuraminidase inhibitor, zanamivir, reduced plasma neuraminidase activity, enhanced endothelial glycocalyx length, and improved FMD in diabetic mice. In humans, a single-arm trial (NCT04867707) of zanamivir inhalation did not reduce plasma neuraminidase activity, improved glycocalyx length, or enhanced FMD. Although zanamivir plasma concentrations in mice reached 225.8 ± 22.0 ng/mL, in humans were only 40.0 ± 7.2 ng/mL. These results highlight the potential of neuraminidase inhibition for ameliorating endothelial dysfunction in T2D and suggest the current Food and Drug Administration-approved inhaled dosage of zanamivir is insufficient to achieve desired outcomes in humans.NEW & NOTEWORTHY This work identifies neuraminidase as a key mediator of endothelial dysfunction in type 2 diabetes that may serve as a biomarker for impaired endothelial function and predictive of development and progression of cardiovascular pathologies associated with type 2 diabetes (T2D). Data show that intervention with the neuraminidase inhibitor zanamivir at effective plasma concentrations may represent a novel pharmacological strategy for restoring the glycocalyx and ameliorating endothelial dysfunction.
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Diabetes Mellitus Experimental , Diabetes Mellitus Tipo 2 , Doenças Vasculares , Camundongos , Humanos , Animais , Zanamivir/farmacologia , Neuraminidase/química , Neuraminidase/farmacologia , Células Endoteliais , Diabetes Mellitus Tipo 2/tratamento farmacológico , Antivirais/farmacologia , Inibidores Enzimáticos/farmacologiaRESUMO
BACKGROUND: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes. METHODS: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes. RESULTS: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations. CONCLUSION: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.