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Waist-to-height ratio and cardiovascular risk: moving beyond BMI in aging populations 腰高比与心血管疾病风险:在老年人群中超越BMI
IF 7 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-26 DOI: 10.1016/j.lana.2025.101349
Juan C. Pineda, Diana M. Montano, Liesed N. Urbano
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引用次数: 0
Regulatory bodies must critically assess their role in the wellness wave of supplement marketing 监管机构必须严格评估他们在保健品营销的健康浪潮中的作用
IF 7 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-26 DOI: 10.1016/j.lana.2025.101348
Alessandro R. Marcon
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引用次数: 0
Healthcare utilisation across five years among adolescents following metabolic-bariatric surgery; a prospective observational study 代谢性减肥手术后5年青少年的医疗保健利用情况一项前瞻性观察研究
IF 7 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-26 DOI: 10.1016/j.lana.2025.101332
Andrew J. Beamish , Todd Jenkins , Justin R. Ryder , Anita Courcoulas , Robert M. Dorman , Marc Michalsky , Carrol Harmon , Michael Helmrath , Thomas H. Inge

Background

Metabolic and bariatric surgery (MBS) is an effective treatment for adolescent severe obesity. Little is known about subsequent healthcare utilisation for individuals who have undergone MBS as adolescents, both related and unrelated to the surgical intervention. This study aimed to document healthcare utilisation events across 5 years after MBS, comparing procedure types and evaluating factors associated with these events.

Methods

The Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study prospectively enrolled 228 adolescents prior to MBS (Roux-en-Y gastric bypass or vertical sleeve gastrectomy) across 5 US children's hospitals. Healthcare utilisation event data collection was standardised, and rigorously collected; events were categorised by system and classified as related or unrelated to the MBS intervention. Factors influencing/predicting the likelihood of healthcare utilisation events were evaluated using negative binomial regression modelling.

Findings

Mean baseline age and body mass index (BMI) of participants at surgery were 17 ± 1·6 years and 53 kg/m2, respectively. Related healthcare utilisation events numbered 141 in 81 participants (67·3 per 500 person-years, 95% CI 53·4–84·9). A total of 224 unrelated healthcare utilisation events unrelated occurred in 112 individuals (107·4 per 500 person-years, 95% CI 94·2–122·5). Over 5 years, participants with a complication within 30 days of surgery had significantly higher rates of subsequent healthcare utilisation events. No difference in rates by surgical procedures was observed for related events or events with hospital admission. However, among participants without baseline type 2 diabetes, vertical sleeve gastrectomy was associated with higher rates of unrelated events compared to Roux-en-Y gastric bypass. Fifty-two percent of events involved admission to hospital, with no difference by procedure, but higher admission rates were observed with higher BMI and hypertension at baseline.

Interpretation

Healthcare utilisation events were common after bariatric surgery and early post-operative surgical complications predicted later healthcare utilisation events. Healthcare utilisation events were more common after sleeve gastrectomy than RYGB in patients without type 2 diabetes at baseline. Findings will better inform surgical candidates of real-world expectations after surgery, and allow providers to consider closer monitoring of those with a 30-day healthcare utilisation event.

Funding

National Institutes for Health (NIH) research support was provided through the following grants: NIH UM1DK072493 and NIH UM1DK095710. The contents of this manuscript are the authors’ sole responsibility and do not necessarily represent official NIH views.
背景:代谢与减肥手术(MBS)是治疗青少年严重肥胖的有效方法。对于青少年时期接受过MBS的个体的后续医疗保健利用情况,无论是与手术干预相关还是无关,我们所知甚少。本研究旨在记录MBS后5年内的医疗保健利用事件,比较手术类型并评估与这些事件相关的因素。方法青少年减肥手术纵向评估(Teen-LABS)研究前瞻性纳入了美国5家儿童医院的228名接受MBS (Roux-en-Y胃旁路或垂直袖胃切除术)治疗的青少年。医疗保健利用事件数据收集是标准化的,并严格收集;事件按系统分类,并分为与MBS干预相关或无关。使用负二项回归模型评估影响/预测医疗保健利用事件可能性的因素。结果:手术时参与者的平均基线年龄和体重指数(BMI)分别为17±1.6岁和53 kg/m2。相关的医疗保健利用事件在81名参与者中有141例(67.3 / 500人-年,95% CI为53.4 - 84.9)。112例患者共发生224例不相关的医疗保健利用事件(每500人年107例,95% CI为94.2 - 122.5)。在5年的时间里,手术30天内出现并发症的参与者随后的医疗保健利用事件的发生率明显更高。外科手术对相关事件或住院事件的发生率没有观察到差异。然而,在没有基线2型糖尿病的参与者中,与Roux-en-Y胃旁路手术相比,垂直套管胃切除术与更高的不相关事件发生率相关。52%的事件涉及住院,手术没有差异,但观察到基线时BMI和高血压较高的住院率。减肥手术后医疗保健利用事件很常见,早期术后手术并发症预测了后来的医疗保健利用事件。在基线时无2型糖尿病的患者中,袖式胃切除术后的医疗保健利用事件比RYGB更常见。研究结果将更好地告知手术候选人手术后的实际期望,并允许提供者考虑对那些有30天医疗保健利用事件的患者进行更密切的监测。美国国立卫生研究院(NIH)的研究支持通过以下拨款提供:NIH UM1DK072493和NIH UM1DK095710。这份手稿的内容是作者的唯一责任,并不一定代表NIH的官方观点。
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引用次数: 0
Sex differences in the association of vascular risk and APOE Genotype with cognitive decline and dementia: evidence from a U.S. longitudinal study 血管风险和APOE基因型与认知能力下降和痴呆相关的性别差异:来自美国纵向研究的证据
IF 7 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-26 DOI: 10.1016/j.lana.2025.101346
Longjian Liu , Jintong Hou , Saishi Cui , Xiaopeng Zhao , Zuolu Liu , J. Craig Longenecker , Nathalie S. May , Jin Jun Luo , Rose Ann DiMaria-Ghalili , Howard J. Eisen

Background

Sex differences in the association between vascular factors and cognitive outcomes remain unclear. We aimed to investigate the associations of blood pressure metrics (hypertension, systolic blood pressure [SBP), pulse pressure, ankle and brachial pressures, and ankle to brachial pressure index [ABI]) with the risk of cognitive decline and dementia.

Methods

We conducted a population-based longitudinal analysis using data from the Atherosclerosis Risk in Communities (ARIC) study (begun in 1987–1989) in the United States. We analyzed a total of 12,268 participants aged 45–64 years who had validated exposure measurements, cognitive function tests (first administrated 1990–1992), and followed up for incidence of dementia through December 2019. Cognitive function was assessed using the Digit Symbol Substitution Test, the Delayed Word Recall Test, and the Word Fluency Test. Dementia cases were identified through a standardized clinical evaluation process, mostly adjudicated by expert reviewers. We performed sex-stratified analyses to examine the associations of blood pressure metrics and APOE ε4 allele with the risk of cognitive decline and dementia.

Findings

Over a median follow-up of 26.4 years, 2698 participants developed dementia. Women aged 55–64 had a significantly higher incidence of dementia than men aged 55–64 (14.8 vs. 11.8 per 1000 person-years; p < 0.0001). After adjusting for key covariates, SBP, pulse pressure, ankle and brachial pressures were significantly associated with cognitive decline in women (p < 0.05). In men, pulse pressure and ankle pressure showed a significant association. In longitudinal analyses, baseline hypertension and elevated brachial pressure were significantly associated with increased dementia risk in women, whereas in men, elevated brachial pressure and decreased ABI were significantly associated with dementia risk. Individuals with APOE ε4 allele had significantly higher risk of dementia in both sexes. A joint effect of APOE ε4 allele and elevated blood pressure metrics conferred a greater relative excess risk of dementia in women vs. men.

Interpretation

These findings highlight notable sex differences in the association between vascular factors and cognitive decline and dementia risk. Women appear more vulnerable to both genetic and vascular risk factors, emphasizing the need for sex-specific approaches in research, prevention, and intervention strategies for cognitive impairment.

Funding

NIH.
背景血管因素与认知结果之间的性别差异尚不清楚。我们的目的是研究血压指标(高血压、收缩压(SBP)、脉压、踝和肱压力以及踝肱压力指数[ABI])与认知能力下降和痴呆风险的关系。方法:我们使用美国社区动脉粥样硬化风险(ARIC)研究(始于1987-1989年)的数据进行了一项基于人群的纵向分析。我们共分析了12268名年龄在45-64岁之间的参与者,他们进行了有效的暴露测量、认知功能测试(首次进行于1990-1992年),并随访了到2019年12月的痴呆症发病率。认知功能通过数字符号替代测试、延迟单词回忆测试和单词流畅性测试进行评估。痴呆症病例是通过标准化的临床评估过程确定的,主要由专家评审人员裁定。我们进行了性别分层分析,以检验血压指标和APOE ε4等位基因与认知能力下降和痴呆风险的关系。在中位26.4年的随访中,2698名参与者患上了痴呆症。55-64岁女性的痴呆发病率明显高于55-64岁男性(14.8 vs 11.8 / 1000人年;p < 0.0001)。调整关键协变量后,收缩压、脉压、踝压和肱压与女性认知能力下降显著相关(p < 0.05)。在男性中,脉压和踝压显示出显著的相关性。在纵向分析中,基线高血压和臂压升高与女性痴呆风险增加显著相关,而在男性中,臂压升高和ABI降低与痴呆风险显著相关。携带APOE ε4等位基因的个体在两性中痴呆风险均显著增高。APOE ε4等位基因和升高的血压指标的共同作用使女性患痴呆的相对风险高于男性。这些发现强调了血管因素与认知能力下降和痴呆风险之间的显著性别差异。女性似乎更容易受到遗传和血管危险因素的影响,这强调了在认知障碍的研究、预防和干预策略中需要针对性别的方法。
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引用次数: 0
Ethical challenges and opportunities for integrating predictive analytics in community-based overdose prevention 在社区过量预防中整合预测分析的伦理挑战和机遇
IF 7 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-23 DOI: 10.1016/j.lana.2025.101345
Bennett Allen , Adelya Urmanche , Brenda Curtis , Celia Fisher
As predictive analytics become more widely integrated into local public health responses to the United States overdose epidemic, community-based substance use service providers have begun to adopt machine learning-based predictive tools to guide the allocation and delivery of overdose prevention services. While these tools hold promise for anticipating community overdose risk and enhancing the efficiency of overdose prevention resource distribution, outreach, and education efforts, their use in community settings raises substantial ethical and practical challenges. In this Viewpoint, we examine the application of predictive analytics to community-based overdose prevention through a public health ethics lens, drawing on principles of distributive justice, transparency, community participation, and implementation readiness. We outline five key ethical considerations for developers (i.e., institutional responsibility, oversimplification of complex social realities, data and algorithmic bias, community displacement in decision making, and equity trade-offs) and corresponding practical challenges for service providers. We offer five recommendations for developers, public health authorities, and frontline organizations to overcome challenges and ensure responsible, equity-driven implementation. As data-driven approaches to overdose prevention proliferate, ethical and participatory frameworks will be essential to ensure predictive tools strengthen, rather than undermine, community trust and health equity.
随着预测分析更广泛地融入美国过量流行的地方公共卫生对策,以社区为基础的物质使用服务提供者已开始采用基于机器学习的预测工具来指导过量预防服务的分配和提供。虽然这些工具有望预测社区过量风险并提高过量预防资源分配、推广和教育工作的效率,但它们在社区环境中的使用带来了重大的道德和实际挑战。在本观点中,我们通过公共卫生伦理视角,借鉴分配正义、透明度、社区参与和实施准备等原则,研究了预测分析在社区过量预防中的应用。我们概述了开发者的五个关键道德考虑因素(即机构责任、复杂社会现实的过度简化、数据和算法偏见、决策中的社区迁移和公平权衡)以及服务提供商面临的相应实际挑战。我们为开发者、公共卫生当局和一线组织提供了五条建议,以克服挑战并确保负责任、公平驱动的实施。随着数据驱动的过量预防方法的激增,道德和参与性框架对于确保预测工具加强而不是破坏社区信任和卫生公平至关重要。
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引用次数: 0
Maternal RSV vaccination to protect infants in Brazil: a model-based cost-effectiveness analysis for incorporation into the National Immunisation Program 巴西母亲RSV疫苗接种以保护婴儿:纳入国家免疫规划的基于模型的成本效益分析
IF 7 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-22 DOI: 10.1016/j.lana.2025.101356
Sophia Aguiar Monteiro Borges , Erick Ohanesian Polli , Ana Carolina Nonato , Natacha Cerchiari , Stéphane Verguet , Ana Marli Christovam Sartori , Patrícia Coelho de Soárez

Background

In Brazil, respiratory syncytial virus (RSV) is the primary cause of lower respiratory tract infections (LRTI) in children under two years of age. Maternal immunization with the bivalent RSV prefusion F protein vaccine (RSVpreF) has demonstrated high efficacy in protecting infants during their first 6 months of life against RSV-LRTI. We assessed the cost-effectiveness of implementing maternal RSV immunization in Brazil.

Methods

We utilised a decision tree model, following a birth cohort during their first year of life. The model compared two strategies: maternal vaccination and no vaccination, from both healthcare system and societal perspectives. Secondary data from Brazilian Health Information Systems, administrative databases and international literature were used. The primary outcome was the incremental cost-effectiveness ratio (ICER) expressed as incremental cost per disability-adjusted life year (DALY) averted, in 2023 USD. We applied a cost-effectiveness threshold of 8000 USD (40,000 BRL) per DALY based on Brazilian guidelines.

Findings

Introduction of RSV vaccination for pregnant women at 50% coverage would prevent around 37,000 RSV cases annually, including 9400 hospitalizations and 28,000 outpatient visits. The program would avert 80 deaths and 1660 DALYs, with an incremental cost of $49,200,000 USD from the healthcare system perspective (ICER $29,700 per DALY averted) and $48,800,000 USD from the societal perspective (ICER $29,200 per DALY averted). These ICERs exceed the acceptable cost-effectiveness Brazilian threshold. To be considered cost-effective, the vaccine dose price would need to be around $12. In sensitivity analyses, vaccine price and efficacy were the most influential parameters, as testing their uncertainty ranges resulted in the largest changes (i.e., the widest range) in the ICER. In the probabilistic sensitivity analysis, the probability that the maternal RSV immunization program is cost-effective at the Brazilian threshold of $8000 per DALY averted was 0% from the healthcare system perspective and 6% from the societal perspective.

Interpretation

Our findings indicate maternal RSV immunization could substantially reduce disease burden but would require significant price reduction to meet Brazil's cost-effectiveness threshold.

Funding

São Paulo Research Foundation (FAPESP), Pan American Health Organization (PAHO) and Brazilian National Council for Scientific and Technological Development (CNPq).
在巴西,呼吸道合胞病毒(RSV)是2岁以下儿童下呼吸道感染(LRTI)的主要原因。母亲接种二价RSV预融合F蛋白疫苗(RSVpreF)在婴儿出生后头6个月内对RSV- lrti具有很高的保护作用。我们评估了在巴西实施母亲RSV免疫接种的成本效益。方法:我们采用决策树模型,对出生队列进行第一年的随访。该模型从卫生保健系统和社会的角度比较了两种策略:母亲接种疫苗和不接种疫苗。次要数据来自巴西卫生信息系统、行政数据库和国际文献。主要结局是增量成本-效果比(ICER),以2023美元表示为每个残疾调整生命年(DALY)避免的增量成本。根据巴西的指导方针,我们采用了每个DALY 8000美元(40,000巴西雷亚尔)的成本效益阈值。研究发现,在50%覆盖率的孕妇中引入RSV疫苗接种,每年可预防约37,000例RSV病例,包括9400例住院和28,000例门诊就诊。该计划将避免80例死亡和1660例伤残调整年,从医疗保健系统角度来看,增量成本为4920万美元(每避免伤残调整年为29700美元),从社会角度来看,增量成本为4880万美元(每避免伤残调整年为29200美元)。这些ICERs超过了巴西可接受的成本效益门槛。要被认为具有成本效益,疫苗剂量的价格需要在12美元左右。在敏感性分析中,疫苗价格和效力是影响最大的参数,因为测试它们的不确定范围导致ICER的最大变化(即最宽的范围)。在概率敏感性分析中,从医疗保健系统的角度来看,母亲RSV免疫规划在巴西阈值(每个DALY避免8000美元)下具有成本效益的概率为0%,从社会角度来看为6%。我们的研究结果表明,母亲RSV免疫接种可以大大减少疾病负担,但需要大幅降低价格才能达到巴西的成本效益门槛。资助:圣保罗研究基金会(FAPESP)、泛美卫生组织(PAHO)和巴西国家科学技术发展委员会(CNPq)。
{"title":"Maternal RSV vaccination to protect infants in Brazil: a model-based cost-effectiveness analysis for incorporation into the National Immunisation Program","authors":"Sophia Aguiar Monteiro Borges ,&nbsp;Erick Ohanesian Polli ,&nbsp;Ana Carolina Nonato ,&nbsp;Natacha Cerchiari ,&nbsp;Stéphane Verguet ,&nbsp;Ana Marli Christovam Sartori ,&nbsp;Patrícia Coelho de Soárez","doi":"10.1016/j.lana.2025.101356","DOIUrl":"10.1016/j.lana.2025.101356","url":null,"abstract":"<div><h3>Background</h3><div>In Brazil, respiratory syncytial virus (RSV) is the primary cause of lower respiratory tract infections (LRTI) in children under two years of age. Maternal immunization with the bivalent RSV prefusion F protein vaccine (RSVpreF) has demonstrated high efficacy in protecting infants during their first 6 months of life against RSV-LRTI. We assessed the cost-effectiveness of implementing maternal RSV immunization in Brazil.</div></div><div><h3>Methods</h3><div>We utilised a decision tree model, following a birth cohort during their first year of life. The model compared two strategies: maternal vaccination and no vaccination, from both healthcare system and societal perspectives. Secondary data from Brazilian Health Information Systems, administrative databases and international literature were used. The primary outcome was the incremental cost-effectiveness ratio (ICER) expressed as incremental cost per disability-adjusted life year (DALY) averted, in 2023 USD. We applied a cost-effectiveness threshold of 8000 USD (40,000 BRL) per DALY based on Brazilian guidelines.</div></div><div><h3>Findings</h3><div>Introduction of RSV vaccination for pregnant women at 50% coverage would prevent around 37,000 RSV cases annually, including 9400 hospitalizations and 28,000 outpatient visits. The program would avert 80 deaths and 1660 DALYs, with an incremental cost of $49,200,000 USD from the healthcare system perspective (ICER $29,700 per DALY averted) and $48,800,000 USD from the societal perspective (ICER $29,200 per DALY averted). These ICERs exceed the acceptable cost-effectiveness Brazilian threshold. To be considered cost-effective, the vaccine dose price would need to be around $12. In sensitivity analyses, vaccine price and efficacy were the most influential parameters, as testing their uncertainty ranges resulted in the largest changes (i.e., the widest range) in the ICER. In the probabilistic sensitivity analysis, the probability that the maternal RSV immunization program is cost-effective at the Brazilian threshold of $8000 per DALY averted was 0% from the healthcare system perspective and 6% from the societal perspective.</div></div><div><h3>Interpretation</h3><div>Our findings indicate maternal RSV immunization could substantially reduce disease burden but would require significant price reduction to meet Brazil's cost-effectiveness threshold.</div></div><div><h3>Funding</h3><div><span>São Paulo Research Foundation</span> (FAPESP), <span>Pan American Health Organization</span> (PAHO) and <span>Brazilian National Council for Scientific and Technological Development</span> (CNPq).</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"53 ","pages":"Article 101356"},"PeriodicalIF":7.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145839177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Retail pharmacy clinics in Mexico: a commentary 墨西哥的零售药房诊所:评论
IF 7 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-22 DOI: 10.1016/j.lana.2025.101341
M. Arantxa Colchero , Tonatiuh Barrientos-Gutiérrez , Mauricio Hernández-Ávila
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引用次数: 0
Economic burden of Chagas disease in Latin American countries: a population-based cost-of-illness analysis from the RAISE study 拉丁美洲国家恰加斯病的经济负担:来自RAISE研究的基于人群的疾病成本分析
IF 7 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-20 DOI: 10.1016/j.lana.2025.101340
Mônica Viegas Andrade , Kenya Valeria Micaela de Souza Noronha , Aline de Souza , Nayara Abreu Julião , André Soares Motta-Santos , Paulo Estevão Franco Braga , Henrique Bracarense , André Batista Alves do Santos , Bruno Ramos Nascimento , Ísis Eloah Machado , Francisco Rogerlândio Martins-Melo , Israel Molina , Pablo Perel , Yvonne Geissbühler , Caroline Demacq , Hector Eduardo Castro Jaramillo , Luis Eduardo Echeverría , Mario Bruno Principato , Luisa Fernanda Aguilera Mora , Marisa Liliana Fernandez , Antonio Luiz Pinho Ribeiro

Background

Chagas disease (ChD) remains a public health concern in Latin America. Despite a decline in overall prevalence, the chronic symptomatic forms still impose a substantial epidemiological and economic burden. This study undertakes a comprehensive, population-based cost analysis of chronic Chagas disease (CCD) from a societal perspective in seven endemic Latin American countries for 2010 and 2023.

Methods

A Markov model with one-year cycles and six states was employed. Direct medical and indirect costs, converted to 2024 purchasing power parity US dollars, were estimated using prevalence data from the Global Burden of Disease Study 2023. Based on a previous Brazilian Markov model, parameters were adjusted using healthcare coverage and per capita health expenditure ratios for each country, further validated by national experts.

Findings

In 2010, Brazil (US$252 billion) and Argentina (US$164 billion) had the highest lifetime burdens. As a percentage of annual Gross Domestic Product, Bolivia (0·9%) and Argentina (0·8%) were most affected. CCD accounted for 6% of total health expenditures in both countries. Between 2010 and 2023, most countries experienced a decline in economic burden due to decreased CCD prevalence, despite an increased proportion of patients with cardiac conditions, reflecting population aging and disease progression.

Interpretation

CCD imposes substantial economic burden across Latin American countries. Epidemiological shift to older populations with severe cardiac forms signals increased healthcare demands. Findings inform policymakers for resource allocation and tailored interventions.

Funding

Funding was provided by Novartis Pharma AG as part of a research collaboration with the World Heart Federation (project number CLCZ696D2010R).
恰加斯病(ChD)仍然是拉丁美洲的一个公共卫生问题。尽管总体流行率有所下降,但慢性症状形式仍然造成重大的流行病学和经济负担。本研究从社会角度对2010年和2023年拉丁美洲七个流行国家的慢性恰加斯病(CCD)进行了全面的、基于人群的成本分析。方法采用1年周期、6个状态的马尔可夫模型。使用《2023年全球疾病负担研究》的患病率数据估算了转换为2024年购买力平价美元的直接医疗和间接成本。基于先前的巴西马尔可夫模型,使用每个国家的医疗保健覆盖率和人均医疗支出比率来调整参数,并由国家专家进一步验证。2010年,巴西(2520亿美元)和阿根廷(1640亿美元)的终生负担最高。作为年度国内生产总值的百分比,玻利维亚(0.9%)和阿根廷(0.8%)受到的影响最大。在这两个国家,CCD占卫生总支出的6%。2010年至2023年期间,尽管患有心脏病的患者比例增加,但由于CCD患病率下降,大多数国家的经济负担有所下降,这反映出人口老龄化和疾病进展。ccd给拉丁美洲国家带来了巨大的经济负担。流行病学向患有严重心脏疾病的老年人群转移表明医疗保健需求增加。研究结果为决策者提供了资源分配和量身定制干预措施的信息。资金由诺华制药公司提供,作为与世界心脏联合会研究合作的一部分(项目编号CLCZ696D2010R)。
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引用次数: 0
Effect of eggs on Maya child development and growth: the Saqmolo’ Project randomized clinical trial 鸡蛋对玛雅儿童发育和生长的影响:Saqmolo项目随机临床试验
IF 7 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-20 DOI: 10.1016/j.lana.2025.101339
Gabriela Montenegro-Bethancourt , Gabriela V. Proaño , Elizabeth Yakes Jimenez , Taylor C. Wallace , Alison Steiber , Xingya Ma , Ming Ji , Peter Rohloff

Background

There is worldwide interest in determining whether frequent egg provision during complementary feeding enhances child development and growth in low-resource settings. We evaluated effects of adding one whole egg per day to local standard nutrition care on infant outcomes.

Methods

The Saqmolo’ Project individually randomized, partially blinded, comparative effectiveness clinical trial was conducted in rural Guatemala from 2021 to 2023. Maya infants aged 6–9 months were randomized to standard nutrition care alone (growth monitoring, complementary and responsive feeding education, deworming medication, multiple micronutrient powders, and referrals for medical care) versus standard care plus one whole egg per day for 6 months. Mixed linear or logistic regression models were used to estimate between-group differences in primary (global development score) and secondary (growth, anemia status, and diet quality) outcomes.

Findings

This trial included 1200 Maya infants (51.3% male). After adjustment for baseline values and participant characteristics, there was no significant between-group difference in global development score (β −0.08 points [95% CI −0.22 to 0.06]). There were also no significant between-group differences for most secondary outcomes. Intervention participants did have significantly higher odds of stunting (odds ratio [OR] 1.42 [95% CI 1.10–1.82]; p = 0.007) and of meeting minimum dietary diversity (OR 1.41 [95% CI 1.20–1.65]; p < 0.001) and minimum adequate diet (OR 1.44 [95% CI 1.26–1.64]; p < 0.001) benchmarks than standard care participants.

Interpretation

Provision of one whole egg per day in addition to standard care improved diet quality but did not benefit development, growth, or anemia status among Maya infants.

Funding

Academy of Nutrition and Dietetics Foundation via an Egg Nutrition Center investigator-initiated research grant.
在低资源环境下,确定补充喂养期间频繁提供鸡蛋是否能促进儿童发育和生长,是全世界都感兴趣的问题。我们评估了在当地标准营养护理中每天添加一个全蛋对婴儿结局的影响。方法于2021 - 2023年在危地马拉农村地区进行Saqmolo项目随机、部分盲法临床试验。6 - 9个月的玛雅婴儿被随机分配到单独的标准营养护理组(生长监测、补充和反应性喂养教育、驱虫药物、多种微量营养素粉末和转诊医疗护理组)和标准护理组,每天加一个完整的鸡蛋,持续6个月。使用混合线性或逻辑回归模型来估计主要(总体发展评分)和次要(生长、贫血状况和饮食质量)结局的组间差异。该试验包括1200名玛雅婴儿(51.3%为男性)。调整基线值和参与者特征后,总体发展评分组间无显著差异(β - 0.08分[95% CI - 0.22 - 0.06])。在大多数次要结果方面,组间也没有显著差异。与标准护理参与者相比,干预参与者发育迟缓的几率(比值比[OR] 1.42 [95% CI 1.10-1.82]; p = 0.007)、满足最低饮食多样性(比值比[OR] 1.41 [95% CI 1.20-1.65]; p < 0.001)和最低适当饮食(比值比[OR] 1.44 [95% CI 1.26-1.64]; p < 0.001)的几率明显更高。解释:除了标准护理外,每天提供一个全蛋改善了玛雅婴儿的饮食质量,但对发育、生长或贫血状况没有好处。营养与饮食学会基金会通过鸡蛋营养中心研究者发起的研究资助。
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引用次数: 0
Advancing real-world evidence in Brazil: regulatory gaps and global lessons 在巴西推进现实证据:监管差距和全球经验教训
IF 7 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-20 DOI: 10.1016/j.lana.2025.101344
Nélio Cézar de Aquino , Cadiele Oliana Reichert , Luis Alberto de Padua Covas Lage , Hebert Fabricio Culler , Felipe Santa Rosa Roitberg , Vanderson Rocha , Flávia Neves Rocha Alves , Juliana Pereira
Regulatory agencies are increasingly incorporating real-world data (RWD) and real-world evidence (RWE) into decision-making frameworks to complement randomized clinical trials. While some regions, such as the U.S. and EU, have developed structured approaches for RWE use, Brazil's regulatory environment remains comparatively limited. This study examines the status of RWE regulatory integration in Brazil through an analysis of normative documents, institutional publications, and selected case studies, using a comparative policy perspective. Although advances have been made in data standardization and the publication of technical guidelines, such as ANVISA's Guidance No. 64/2023, the practical use of RWE in regulatory processes is still nascent. Key challenges include fragmented data infrastructure, and limited intersectoral coordination. Addressing these gaps will require improved interoperability across health information systems, convergence of methodological standards, and sustained collaboration among regulatory authorities, academia, and data holders to enable consistent and scientifically robust use of RWE in the Brazilian context and, potentially, in other low- and middle-income countries.
监管机构越来越多地将真实世界数据(RWD)和真实世界证据(RWE)纳入决策框架,以补充随机临床试验。虽然美国和欧盟等一些地区已经为莱茵集团制定了结构化的方法,但巴西的监管环境仍然相对有限。本研究采用比较政策的视角,通过对规范性文件、机构出版物和选定案例研究的分析,考察了巴西RWE监管一体化的现状。尽管在数据标准化和技术指南(如ANVISA的第64/2023号指南)的出版方面取得了进展,但RWE在监管过程中的实际应用仍处于起步阶段。主要挑战包括分散的数据基础设施和有限的部门间协调。解决这些差距将需要改进卫生信息系统之间的互操作性,统一方法标准,以及监管当局、学术界和数据持有者之间的持续合作,以便在巴西以及可能在其他低收入和中等收入国家持续和科学地使用RWE。
{"title":"Advancing real-world evidence in Brazil: regulatory gaps and global lessons","authors":"Nélio Cézar de Aquino ,&nbsp;Cadiele Oliana Reichert ,&nbsp;Luis Alberto de Padua Covas Lage ,&nbsp;Hebert Fabricio Culler ,&nbsp;Felipe Santa Rosa Roitberg ,&nbsp;Vanderson Rocha ,&nbsp;Flávia Neves Rocha Alves ,&nbsp;Juliana Pereira","doi":"10.1016/j.lana.2025.101344","DOIUrl":"10.1016/j.lana.2025.101344","url":null,"abstract":"<div><div>Regulatory agencies are increasingly incorporating real-world data (RWD) and real-world evidence (RWE) into decision-making frameworks to complement randomized clinical trials. While some regions, such as the U.S. and EU, have developed structured approaches for RWE use, Brazil's regulatory environment remains comparatively limited. This study examines the status of RWE regulatory integration in Brazil through an analysis of normative documents, institutional publications, and selected case studies, using a comparative policy perspective. Although advances have been made in data standardization and the publication of technical guidelines, such as ANVISA's Guidance No. 64/2023, the practical use of RWE in regulatory processes is still nascent. Key challenges include fragmented data infrastructure, and limited intersectoral coordination. Addressing these gaps will require improved interoperability across health information systems, convergence of methodological standards, and sustained collaboration among regulatory authorities, academia, and data holders to enable consistent and scientifically robust use of RWE in the Brazilian context and, potentially, in other low- and middle-income countries.</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"55 ","pages":"Article 101344"},"PeriodicalIF":7.0,"publicationDate":"2025-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145792268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Lancet Regional Health-Americas
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