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Rationale and Design of the CREATE Trial: A Multicenter, Randomized Comparison of Continuation or Cessation of Single Antithrombotic Therapy at 1 Year After Transcatheter Aortic Valve Replacement.
Get PDFBACKGROUND: Current guidelines and expert consensus recommend lifelong single antiplatelet therapy for patients undergoing transcatheter aortic valve replacement who have no indication for anticoagulation or dual antiplatelet therapy. However, there is no direct evidence from randomized controlled trials supporting this practice. Furthermore, the optimal duration of antiplatelet therapy in this population has not been adequately investigated. METHODS AND RESULTS: CREATE (A Multicenter Randomized Controlled Study to Evaluate Cessation of Antithrombotic Therapy at 1 Year in TAVR Patients-The CREATE Study) is a prospective, multicenter, open-label, randomized controlled trial for patients who have undergone successful transcatheter aortic valve replacement and have no indication for long-term oral anticoagulation or antiplatelet therapy. Eligible patients are free from major bleeding and ischemic events for 1 year postprocedure before being randomized 1:1 to single antiplatelet therapy (control group) or no antiplatelet therapy (experimental group). The primary efficacy end point is the incidence of bleeding events, defined by the VARC-3 (Valve Academic Research Consortium-3) criteria, at 1-year postrandomization. The primary safety end point is a composite of cardiac death, myocardial infarction, and ischemic stroke at 1 year. The trial is powered for both superiority in efficiency and noninferiority in safety. Accordingly, a total of 3380 patients will be enrolled. CONCLUSIONS: The CREATE trial aims to assess if stopping antiplatelet therapy at 1-year after transcatheter aortic valve replacement reduces bleeding risk without increasing ischemic events in patients not requiring chronic antithrombotic therapy. REGISTRATION: URL: https://www.chictr.org.cn; Unique identifier: ChiCTR2400087454
Harnessing artificial intelligence to address diseases attributable to unsafe drinking water: challenges, potentials, and recommendations
Get PDFUnsafe drinking water is a global concern that poses serious risks to public health, especially in developing nations, where tainted water can spread diseases such as cholera, polio, and diarrhea, which can result in several health issues and deaths. Children and immunocompromised people are the most vulnerable groups that suffer disproportionately from waterborne illnesses. Promising approaches to reduce the burden of waterborne diseases and revolutionize drinking water management are provided by artificial intelligence (AI). Public health authorities and water industries can improve safe drinking water distribution, treatment, and monitoring using AI-powered models and approaches. AI enables predictive modeling to support sustainable water management techniques, maximize resource usage, and identify problems with infrastructure and water quality earlier. AI, coupled with Geographic Information Systems (GIS) and machine learning (ML) models such as random forest classifiers, aids in cholera risk prediction and enhances waterborne disease detection. Advanced AI models facilitate drought forecasting, reservoir optimization, and real-time water monitoring, improving water management and resource conservation. AI-driven systems, including predictive analytics and intelligent water distribution models, show potential for enhancing water safety, mitigating risks, and promoting sustainable water practices. However, several challenges must be overcome when incorporating AI into water management, such as concerns about data quality, infrastructure constraints, and ethical difficulties. Genetic sequencing and metagenomic analyses, which provide insights into microbial dynamics and water quality maintenance, are potential future areas in AI applications for water management. A balanced approach prioritizing equitable deployment, infrastructure readiness, workforce development, robust governance, collaborative efforts, ethical standards, and transparent regulatory frameworks, ensuring social equity and economic efficiency with current norms and policies, is required for AI integration to address diseases attributable to unsafe drinking water. These AI models are expedient to fully optimize WASH disease management to increase access to clean water, reduce the incidence of waterborne diseases, and advance global health
Need for planetary health perspective in guidance for complex interventions for climate and health.
No full textLorna Benton and colleagues argue that including planetary health in guidance for researchers would help to prioritise effective responses to current environmental and human crise
Pathways of service user participation in mental health decision-making in Lebanon
Get PDFInclusive participation of mental health service users is critical for effective decision-making and governance, yet remains underexplored in humanitarian settings. Lebanon, facing protracted crises and hosting over 1.5 million Syrian refugees, provides a unique case to examine pathways of service user participation in mental health decision-making. This qualitative study investigates barriers, facilitators, and power dynamics influencing service user participation at the micro-, meso- (service), and macro- (policy) levels. Semi-structured interviews and focus group discussions were conducted with 33 purposively selected participants, including Syrian and Lebanese service users, NGO staff, and UN representatives. Data were collaboratively analysed using Dedoose software based on codes developed deductively and inductively. Our findings reveal that participation is limited and predominantly consultative, with power imbalances including gender, socioeconomic status, stigma, and displacement status creating significant barriers. Users reported decision-making power at the individual level, particularly in seeking services and treatment planning, but meaningful participation at service or governance levels was rare. Providers highlighted efforts to gather user input but often framed participation as part of routine monitoring and evaluation. Reluctance to engage formal governance structures, due to mistrust and structural and attitudinal barriers, further inhibited participation. Strategies to enhance meaningful participation include increasing awareness, capacity-building, promoting flexibility in service design, and strengthening user-led advocacy. Addressing power imbalances and promoting inclusive, user-centered approaches are essential to advancing inclusion in mental health systems, with valuable implications for humanitarian and crisis-affected settings globally
The effect of non-optimal ambient temperature on daily mortality in Colombia 2010-2019.
Get PDFAdverse effects of non-optimal temperatures on mortality have been reported in different climates. However, only a low number of studies have been conducted in tropical locations where these effects might differ. Here, we estimate the association between ambient air temperature and all-cause mortality and assess the impact of non-optimal temperatures on attributable mortality at national and subnational levels in Colombia during 2010-2019. We obtained daily temperature and mortality data for 32 departments and conducted a two-stage analysis. In stage-1 we fitted a time-series Poisson model for each department and estimated the mortality-temperature association using distributed-lag-nonlinear models with 7-28 days of lag. In stage-2, we pooled these estimates using a multivariate meta-analytic model including mean temperature, relative humidity, and a multidimensional poverty index. We calculated attributable deaths and fractions due to non-optimal temperatures and due to overall heat and cold. We analyzed 2,561,561 deaths and found marked differences in exposure-response curves of mortality-temperature, where most departments showed acute heat effects but no cold effects for the 7-days lag. This lag-response curve for heat showed that the risk of death is higher during the same day (lag 0) of extreme temperatures and decreases after the third day. The country attributable fraction due to non-optimal temperature was higher for heat (1.77, 95% CI 1.16 - 2.31) during the 0-7 days lag, but higher for cold temperatures (4.68, 95% CI 2.34 - 6.72) during the 0-28 days lag. There was high heterogeneity in the estimated risks between departments. These results should inform planning adaptation strategies for climate change differentiated at subnational level
Use of anthracyclines and trastuzumab for breast cancer in women with and without a history of cardiovascular disease in Sweden: a national cross-sectional study.
Get PDFBACKGROUND: Cardiovascular toxicity concerns have limited the use of anthracyclines and trastuzumab among breast cancer patients with cardiovascular disease (CVD) but evidence on real-world prescribing patterns is scarce. We aimed to describe the use of these drugs in women with and without CVD when diagnosed with non-metastatic breast cancer in Sweden. METHODS: Using Swedish national registers (2010-15), we identified breast cancer treatment and prior CVD from hospital and prescription data. We calculated prevalence of anthracycline and trastuzumab use in women with and without prior CVD, and estimated prevalence ratios (PR) comparing these groups, adjusted for age, stage, and other patient and tumour-related factors. RESULTS: Among 32,590 women with breast cancer, 10,702 (33%) had prior CVD. Anthracycline use was lower in those with vs without prior CVD (2,169/10,702 [20.3%] vs 8,654/21,888 [39.5%], crude PR 0.51, 0.49-0.53); the PR attenuated after adjustment for age and other factors (adj-PR 0.90, 0.87-0.93). There was substantial variation by type of CVD: patients with heart failure were much less likely to receive anthracyclines (adj-PR 0.46, 0.35-0.57) while prior venous thromboembolism (VTE) had no impact (adj-PR 0.98, 0.88-1.09). Among HER2 + patients, trastuzumab use showed similar patterns, with prevalence of 630/1,100 [57.3%] vs 2,279/2,866 [79.5%] for any vs no prior CVD (crude PR = 0.72, 0.68-0.76, adjusted PR = 0.95, 0.90-0.99); adjusted PRs for specific outcomes ranged from 0.77 (0.61-0.93) for heart failure, to 1.04 (0.92-1.15) for VTE. CONCLUSION: While prior CVD was associated with lower use of potentially cardiotoxic breast cancer therapies, substantial numbers of patients with CVD still received these treatments, with marked variation by type of CVD. These real-world data suggest variable cardiovascular toxicity risk stratification before anticancer therapy and highlight the need for evidence-based guidance on negotiating the risk-benefit balance in these patients
The influence of social networks in adoption of integrated health interventions: A qualitative study of fishermen in Malawi.
Get PDFINTRODUCTION: Social networks play a vital role in influencing individual and collective health behaviors and facilitating the diffusion of health interventions. Fishing communities in sub-Saharan Africa face socio-cultural and occupational challenges such as low literacy rates and high mobility. However, their high social cohesion creates a unique social environment for spreading health interventions. We explored the role of social relationships in mediating health intervention adoption in these communities, to inform future intervention strategies. METHODS: We conducted an exploratory phenomenological qualitative study between September and October 2024 nested within a large community cluster randomized trial (the FISH trial) in fishing communities in Mangochi district on the southern tip of Lake Malawi. We conducted four focus group discussions (N = 47) and 16 in-depth interviews. Data were analyzed thematically using a hybrid deductive and inductive data coding approach. RESULTS: Fishermen's social networks included fishing friendships, kin and broader community connections that facilitated knowledge exchange, resource sharing and support provision. Familiarity, trust, desire to conform to community norms and shared community ties enabled health knowledge exchange and encouraged uptake of targeted interventions for HIV and schistosomiasis, despite fishermen's mobility. Other facilitators at individual level included perceived susceptibility and financial incentives. Occasionally, negative rumors spread through peer networks, e.g., a link between blood sample collection and malign government agenda, contributed to disengagement with health interventions. Other factors including HIV-related stigma and prohibitive traditional beliefs interacted with social networks to hinder uptake. DISCUSSION: Fishermen's health decisions are deeply embedded within their social structures. However, other factors operating at the individual and community level were noted to be crucial catalysts of the decision-making process. This study highlights the potential of leveraging social networks in public health strategies for mobile communities so long as they account for critical individual factors that influence health service engagement
Inequities in statin adherence for primary prevention of cardiovascular disease: a historical cohort study in English primary care.
Get PDFBACKGROUND: Cardiovascular disease (CVD) is a leading global health concern. . Statins are effective in reducing CVD risk, but suboptimal adherence limits their potential, yet recent data on this issue is limited, particularly regarding its association with socioeconomic deprivation and ethnicity. METHODS: We analysed English primary care data from the CPRD Aurum database for individuals aged 25 and older who started statin therapy between 1st January 2015 and 31st December 2019, with no prior CVD. Prescription-refill data were used to calculate the proportion of days covered (PDC) within one year. We used logistic regression to examine the relationship between socioeconomic deprivation or ethnicity and suboptimal statin adherence (defined as a PDC<80%) adjusted for age, sex, year of statin prescription, deprivation or ethnicity, comorbidities, smoking and BMI status. We also assessed whether sex might modify these associations. RESULTS: Among the 337,990 individuals included, 32.9% had suboptimal statin adherence. Deprivation was associated with an 11% increase in odds of suboptimal adherence (OR 1.11, 95% CI 1.08-1.13). All ethnic minorities had higher odds of suboptimal adherence compared to the White group (Black: OR 2.00, 1.92-2.08; Mixed: OR 1.49, 1.41-1.56; South-Asian: OR 1.35, 1.31-1.39). Men in deprived areas and of South-Asian ethnicity background had higher odds of suboptimal adherence. CONCLUSION: Suboptimal statins adherence remains a significant issue and a missed opportunity to reduce CVD burden. Adherence inequities exist, and targeted interventions are necessary to address these disparities
Effect of a novel house design (star home) on indoor malaria mosquito abundance in rural Tanzania: secondary outcomes of an open-label, household, randomised controlled trial.
Get PDFBACKGROUND: Screening houses can reduce malaria transmission in sub-Saharan Africa. Our study evaluated whether a novel screened house design (star home) with bedrooms on the second storey reduced indoor mosquito abundance compared with traditional houses in Mtwara, Tanzania. METHODS: In this open-label, household, randomised controlled trial, indoor mosquito abundance was assessed in 110 star homes and 110 neighbouring traditional houses in 59 villages from Jan 5, 2022, to Dec 20, 2023. Mosquitoes were collected using US Centers for Disease Control light traps every 7 weeks. Anopheles gambiae and Anopheles funestus species were identified using PCR and Plasmodium falciparum sporozoites detected using ELISA. Nightly temperature, CO2 concentrations, and duration of door opening was recorded. Differences between study groups were analysed using generalised linear mixed-effects models. The trial is registered with ClinicalTrials.gov (NCT04529434). FINDINGS: Of 9290 mosquitoes collected, 1899 were A gambiae, 69 were A funestus, and 7322 Culex species, mainly Culex quinquefasciatus. Star homes had 51% less A gambiae (adjusted risk ratio [RR] 0·49, 95% CI 0·35 to 0·69; p<0·0001) and 61% less Culex species (RR 0·39, 0·32 to 0·48; p<0·0001) than traditional houses. At night, star homes were 0·5°C cooler (95% CI 0·2 to 0·9; p=0·010), with similar concentrations of CO2 (-7 ppm, 95% CI -19 to 6; p=0·285) and had external doors open 53% less time than traditional houses (7·5 min/h vs 16·2 min/h; p<0·0001). INTERPRETATION: Star homes reduced indoor mosquito abundance and malaria transmission risk compared with traditional houses, demonstrating the protective efficacy of houses that are well screened and air permeable in rural Africa. FUNDING: Hanako Foundation, Singapore
Estimating the potential impact of surveillance test-and-treat posts to reduce malaria in border regions in sub-Saharan Africa: a modelling study.
Get PDFBACKGROUND: The last malaria cases in near-elimination settings are often found in international border regions due to the presence of hard-to-reach populations, conflict, uneven intervention coverage, and human migration. Test-and-treat border posts are an under-researched form of active case detection used to interrupt transmission chains between countries. METHODS: An individual-based, mathematical metapopulation model of Plasmodium falciparum was used to estimate the effectiveness of border screening posts on total cases in malaria-endemic sub-Saharan Africa. RESULTS: The implementation of international border posts across 401 sub-national administrative units would avert a median of 7173 (IQR 1075 to 23,550) cases per unit over a 10 year period and reduce PfPR2-10 by a median of 0.21% (IQR 0.04 to 0.44%). CONCLUSIONS: Border posts were most effective in low-transmission settings with high-transmission neighbours. Border posts alone in sub-Saharan Africa will not allow a country to reach elimination, particularly when considering feasibility and acceptability, but could contribute to broader control packages to targeted populations