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Triangulation of epidemiological evidence and risk of bias evaluation: A proposed framework and applied example using formaldehyde exposure and risk of myeloid leukemias 流行病学证据的三角分析和偏差风险评估:甲醛暴露与骨髓性白血病风险的拟议框架和应用实例
Pub Date : 2024-04-09 DOI: 10.1016/j.gloepi.2024.100143
Daniel J. Lauer , Anthony J. Russell , Heather N. Lynch , William J. Thompson , Kenneth A. Mundt , Harvey Checkoway

Evidence triangulation may help identify the impact of study design elements on study findings and to tease out biased results when evaluating potential causal relationships; however, methods for triangulating epidemiologic evidence are evolving and have not been standardized. Building upon key principles of epidemiologic evidence triangulation and risk of bias assessment, and responding to the National Academies of Sciences, Engineering, and Medicine (NASEM) call for applied triangulation examples, the objective of this manuscript is to propose a triangulation framework and to apply it as an illustrative example to epidemiologic studies examining the possible relationship between occupational formaldehyde exposure and risk of myeloid leukemias (ML) including acute (AML) and chronic (CML) types.

A nine-component triangulation framework for epidemiological evidence was developed incorporating study quality and ROB guidance from various federal health agencies (i.e., US EPA TSCA and NTP OHAT). Several components of the triangulation framework also drew from widely used epidemiological analytic tools such as stratified meta-analysis and sensitivity analysis. Regarding the applied example, fourteen studies were identified and assessed using the following primary study quality domains to explore potential key sources of bias: 1) study design and analysis; 2) study participation; 3) exposure assessment; 4) outcome assessment; and 5) potential confounding. Across studies, methodological limitations possibly contributing to biased results were observed within most domains. Interestingly, results from one study – often providing the largest and least-precise relative risk estimates, likely reflecting study biases, deviated from most primary study findings indicating no such associations. Triangulation of epidemiological evidence appears to be helpful in exploring inconsistent results for the identification of study results possibly reflecting various biases. Nonetheless, triangulation methodologies require additional development and application to real-world examples to enhance objectivity and reproducibility.

证据三角测量有助于确定研究设计要素对研究结果的影响,并在评估潜在因果关系时剔除有偏差的结果;然而,三角测量流行病学证据的方法在不断演变,尚未标准化。本手稿以流行病学证据三角测量和偏倚风险评估的关键原则为基础,响应美国国家科学、工程和医学院(NASEM)征集三角测量应用实例的号召,旨在提出一个三角测量框架,并将其作为一个示例应用于研究职业性甲醛暴露与骨髓性白血病(ML)(包括急性(AML)和慢性(CML)类型)风险之间可能关系的流行病学研究。我们制定了一个由九个部分组成的流行病学证据三角分析框架,其中包含了各联邦卫生机构(即:美国环保署 TSCA 和美国国家卫生研究院)提供的研究质量和 ROB 指南、美国 EPA TSCA 和 NTP OHAT)。三角分析框架的几个组成部分还借鉴了广泛使用的流行病学分析工具,如分层荟萃分析和敏感性分析。在应用实例方面,我们确定了 14 项研究,并使用以下主要研究质量领域对其进行了评估,以探索潜在的关键偏倚来源:1)研究设计与分析;2)研究参与;3)暴露评估;4)结果评估;以及 5)潜在混杂因素。在所有研究中,大多数领域都发现了可能导致结果偏倚的方法学局限性。有趣的是,一项研究的结果--通常提供最大和最不精确的相对风险估计值,可能反映了研究偏差--偏离了大多数主要研究结果,表明没有这种关联。流行病学证据的三角分析似乎有助于探索不一致的结果,以确定可能反映各种偏差的研究结果。不过,三角测量方法需要进一步发展,并应用于现实世界的实例,以提高客观性和可重复性。
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引用次数: 0
Estimating the effect of realistic improvements of metformin adherence on COVID-19 mortality using targeted machine learning 利用定向机器学习估计二甲双胍依从性的实际改善对 COVID-19 死亡率的影响
Pub Date : 2024-03-30 DOI: 10.1016/j.gloepi.2024.100142
Sky Qiu , Alan E. Hubbard , Juan Pablo Gutiérrez , Ganesh Pimpale , Arturo Juárez-Flores , Rakesh Ghosh , Iván de Jesús Ascencio-Montiel , Stefano M. Bertozzi

Background

Type 2 diabetes elevates the risk of severe outcomes in COVID-19 patients, with multiple studies reporting higher case fatality rates. Metformin is a widely used medication for glycemic management. We hypothesize that improved adherence to metformin may lower COVID-19 post-infection mortality risk in this group. Utilizing data from the Mexican Social Security Institute (IMSS), we investigate the relationship between metformin adherence and mortality following COVID-19 infection in patients with chronic metformin prescriptions.

Methods

This is a retrospective cohort study consisting of 61,180 IMSS beneficiaries who received a positive polymerase chain reaction (PCR) or rapid test for SARS-CoV-2 and had at least two consecutive months of metformin prescriptions prior to the positive test. The hypothetical intervention is improved adherence to metformin, measured by proportion of days covered (PDC), with the comparison being the observed metformin adherence values. The primary outcome is all-cause mortality following COVID-19 infection. We defined the causal parameter using shift intervention, an example of modified treatment policies. We used the targeted learning framework for estimation of the target estimand.

Findings

Among COVID-19 positive patients with chronic metformin prescriptions, we found that a 5% and 10% absolute increase in metformin adherence is associated with a respective 0.26% (95% CI: −0.28%, 0.79%) and 1.26% (95% CI: 0.72%, 1.80%) absolute decrease in mortality risk.

Interpretation

Subject to the limitations of a real-world data study, our results indicate a causal association between improved metformin adherence and reduced COVID-19 post-infection mortality risk.

背景2型糖尿病会增加COVID-19患者出现严重后果的风险,多项研究报告了较高的病死率。二甲双胍是一种广泛使用的血糖管理药物。我们假设,改善二甲双胍的依从性可降低该群体感染 COVID-19 后的死亡风险。我们利用墨西哥社会保障局(IMSS)的数据,调查了长期服用二甲双胍的患者在感染 COVID-19 后服用二甲双胍的依从性与死亡率之间的关系。这是一项回顾性队列研究,研究对象包括 61,180 名接受过 SARS-CoV-2 聚合酶链反应(PCR)或快速检测呈阳性,且在检测呈阳性前至少连续两个月服用二甲双胍的墨西哥社会保障局受益人。假设的干预措施是提高二甲双胍的依从性,以覆盖天数比例(PDC)来衡量,比较值是观察到的二甲双胍依从性值。主要结果是 COVID-19 感染后的全因死亡率。我们使用转变干预来定义因果参数,这是修改治疗政策的一个例子。在 COVID-19 阳性且长期服用二甲双胍的患者中,我们发现二甲双胍依从性绝对值提高 5%和 10%,死亡率分别降低 0.26% (95% CI: -0. 28%, 0.79%) 和 0.79%。解释受真实世界数据研究的限制,我们的研究结果表明,二甲双胍依从性的提高与 COVID-19 感染后死亡风险的降低之间存在因果关系。
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引用次数: 0
Quantitative recall bias analysis of the talc and ovarian cancer association 滑石粉与卵巢癌关联的定量回忆偏差分析
Pub Date : 2024-03-11 DOI: 10.1016/j.gloepi.2024.100140
Julie E. Goodman, Leon M. Espira, Ke Zu , Denali Boon
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引用次数: 0
Population attributable fraction of gas cooking and childhood asthma: What was missed? 燃气烹饪与儿童哮喘的人口可归因比例:遗漏了什么?
Pub Date : 2024-03-11 DOI: 10.1016/j.gloepi.2024.100141
Wenchao Li, Julie E. Goodman, Christopher Long
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引用次数: 0
Prevalence and factors associated with anxiety disorder among married women exposed to violence in rural area, Ismailia, Egypt: A cross-sectional study 埃及伊斯梅利亚农村地区遭受暴力侵害的已婚妇女中焦虑症的患病率及其相关因素:横断面研究
Pub Date : 2024-02-12 DOI: 10.1016/j.gloepi.2024.100139
Almaza A. Salim , Mona Elsayed , Mohamed Hafez Mohamed , Heba Yousef , Mohamed S. Hemeda , Alaa Ramadan , Nathan Ezie Kengo , Noha M. Abu Bakr Elsaid

Background

Domestic abuse is a widespread health issue that negatively impacts both mental health and quality of life.

Objectives

To determine the prevalence of domestic violence and anxiety among women visiting primary healthcare facilities in the rural Ismailia governorate.

Methods

Between October 2021 and December 2021, a cross-sectional study was conducted. Simple random methods were used to choose the participants from those who attended a clinic. 350 married women were included in the estimated sample size. By using an interview questionnaire, data were gathered including the following parts: The socio-demographic data, designed scale for assessment of violence and anxiety symptoms were assessed by the Hamilton anxiety scale.

Results

The prevalence of domestic violence was 41% and both physical and sexual abuse was 43%. The most predominant sexual abuse was practice without consent (63%). The prevalence of anxiety was 76%, the predominance was mild degree 46% followed by mild to moderate 18%. The significant predictors for anxiety in the total sample were the increase in age of women, rural residence, and exposure to abuse (OR = 11.2 (4.9–25.4). The use of the husband's stimulant drugs was the most predictor factor for women's abuse (OR = 2.3 (1.4–3.9).

Conclusion

forty-one of the women exposed to every form of violence, anxiety was present in more than three-quarters of the studied women. It is essential to screen any wife attending primary health care for the manifestation of domestic violence especially in rural areas and increase the awareness of family physicians towards screening of mental health problems.

背景 家庭虐待是一个普遍存在的健康问题,对心理健康和生活质量都有负面影响。目标 确定在伊斯梅利亚省农村地区初级医疗机构就诊的妇女中家庭暴力和焦虑的普遍程度。方法 在 2021 年 10 月至 2021 年 12 月期间开展了一项横断面研究。采用简单随机的方法从就诊者中选择参与者。估计样本量包括 350 名已婚妇女。通过使用访谈问卷,收集到的数据包括以下部分:结果家庭暴力的发生率为 41%,身体虐待和性虐待的发生率均为 43%。最主要的性虐待是未经同意的性行为(63%)。焦虑发生率为 76%,以轻度焦虑为主,占 46%,其次是轻中度焦虑,占 18%。在所有样本中,焦虑的重要预测因素是妇女年龄的增加、居住在农村和遭受虐待(OR = 11.2 (4.9-25.4))。丈夫使用兴奋剂是最能预测妇女遭受虐待的因素(OR = 2.3 (1.4-3.9))。有必要对接受初级保健服务的妻子进行家庭暴力表现筛查,尤其是在农村地区,并提高家庭医生对心理健康问题筛查的认识。
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引用次数: 0
Effect of different forms of coconut on the lipid profile in normal free-living healthy subjects: A randomized controlled trial (Phase II) 不同形式的椰子对自由生活的正常健康人血脂状况的影响:随机对照试验(第二阶段)
Pub Date : 2024-02-02 DOI: 10.1016/j.gloepi.2024.100138
Ruvan A.I. Ekanayaka , P.G.S.M. de Silva , Medhani K.I. Ekanayaka , W.M.M. Jayathilake , R.P.M.M.R. Pathirana , Y.N. Amaratunga , Prasadhini J.D. De Silva , Bilesha Perera

Background

It has been postulated that the lipid effects of coconut could be mediated by its fatty acids, fiber and lysine/arginine ratio. Hence, the lipid effects of coconut oil could be different from the effects of the kernel flakes or milk extract because the constituents could be different in each coconut preparation. The present research investigated the lipid effects of different modes of coconut used in food preparation.

Methods

This study involved a total of 190 participants, randomized into four groups, which received coconut oil supplement (30 ml) (n = 53), kernel flakes (30 g) (n = 52) or coconut milk powder (30 g) (n = 44) for a period of 8 weeks. The control group (n = 41) received no supplement. Lipid assays were performed at baseline and at the end of the 4th and 8th weeks. The generalized estimating equations (GEE), ANOVA, and paired and independent t-tests were used in the analysis.

Result

The age range of the participants was 25–60 years, and 52.6% of them (n = 100) were men. Coconut milk supplementation induced beneficial changes in the lipid profile in that the LDL and non-HDL levels decreased while the HDL levels increased. The subgroup whose baseline LDL level was elevated appeared to benefit most from coconut milk supplementation. Coconut oil and kernel flakes failed to induce favorable lipid changes comparable to coconut milk supplementation.

Conclusion

Differing concentrations of protein, fat and fiber in coconut preparations could possibly explain the dissimilar effects on the lipid profile caused by the different coconut preparations. The benefits of coconut milk seen in the high basal LDL subgroup warrant a detailed study.

背景据推测,椰子的脂质效应可能是由其脂肪酸、纤维和赖氨酸/精氨酸比率介导的。因此,椰子油对血脂的影响可能不同于椰子仁片或椰奶提取物,因为每种椰子制剂中的成分可能不同。本研究调查了椰子在食品制作中的不同使用方式对血脂的影响。本研究共涉及 190 名参与者,随机分为四组,分别接受椰子油补充剂(30 毫升)(n = 53)、椰子仁片(30 克)(n = 52)或椰子奶粉(30 克)(n = 44),为期 8 周。对照组(n = 41)不服用任何补充剂。在基线以及第 4 周和第 8 周结束时进行血脂检测。分析采用了广义估计方程(GEE)、方差分析、配对检验和独立 t 检验。补充椰奶后,血脂谱发生了有益的变化,低密度脂蛋白和非高密度脂蛋白水平下降,而高密度脂蛋白水平上升。基线低密度脂蛋白水平升高的亚组似乎从补充椰奶中获益最多。结论椰子制剂中蛋白质、脂肪和纤维的浓度不同,这可能是不同椰子制剂对血脂谱产生不同影响的原因。椰奶对高基础低密度脂蛋白亚组的益处值得进行详细研究。
{"title":"Effect of different forms of coconut on the lipid profile in normal free-living healthy subjects: A randomized controlled trial (Phase II)","authors":"Ruvan A.I. Ekanayaka ,&nbsp;P.G.S.M. de Silva ,&nbsp;Medhani K.I. Ekanayaka ,&nbsp;W.M.M. Jayathilake ,&nbsp;R.P.M.M.R. Pathirana ,&nbsp;Y.N. Amaratunga ,&nbsp;Prasadhini J.D. De Silva ,&nbsp;Bilesha Perera","doi":"10.1016/j.gloepi.2024.100138","DOIUrl":"https://doi.org/10.1016/j.gloepi.2024.100138","url":null,"abstract":"<div><h3>Background</h3><p>It has been postulated that the lipid effects of coconut could be mediated by its fatty acids, fiber and lysine/arginine ratio. Hence, the lipid effects of coconut oil could be different from the effects of the kernel flakes or milk extract because the constituents could be different in each coconut preparation. The present research investigated the lipid effects of different modes of coconut used in food preparation.</p></div><div><h3>Methods</h3><p>This study involved a total of 190 participants, randomized into four groups, which received coconut oil supplement (30 ml) (<em>n</em> = 53), kernel flakes (30 g) (<em>n</em> = 52) or coconut milk powder (30 g) (<em>n</em> = 44) for a period of 8 weeks. The control group (<em>n</em> = 41) received no supplement. Lipid assays were performed at baseline and at the end of the 4th and 8th weeks. The generalized estimating equations (GEE), ANOVA, and paired and independent <em>t-</em>tests were used in the analysis.</p></div><div><h3>Result</h3><p>The age range of the participants was 25–60 years, and 52.6% of them (<em>n</em> = 100) were men. Coconut milk supplementation induced beneficial changes in the lipid profile in that the LDL and non-HDL levels decreased while the HDL levels increased. The subgroup whose baseline LDL level was elevated appeared to benefit most from coconut milk supplementation. Coconut oil and kernel flakes failed to induce favorable lipid changes comparable to coconut milk supplementation.</p></div><div><h3>Conclusion</h3><p>Differing concentrations of protein, fat and fiber in coconut preparations could possibly explain the dissimilar effects on the lipid profile caused by the different coconut preparations. The benefits of coconut milk seen in the high basal LDL subgroup warrant a detailed study.</p></div>","PeriodicalId":36311,"journal":{"name":"Global Epidemiology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S259011332400004X/pdfft?md5=4d92d8d64db8471c0414ee103b4cfbe3&pid=1-s2.0-S259011332400004X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139710145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Occurrence of COVID-19 and serum per- and polyfluoroalkyl substances: A case-control study among workers with a wide range of exposures COVID-19 和血清中的全氟烷基和多氟烷基物质:一项针对接触范围广泛的工人的病例对照研究
Pub Date : 2024-01-07 DOI: 10.1016/j.gloepi.2024.100137
Anna K. Porter , Sarah E. Kleinschmidt , Kara L. Andres , Courtney N. Reusch , Ryan M. Krisko , Oyebode A. Taiwo , Geary W. Olsen , Matthew P. Longnecker

Per- and polyfluoroalkyl substances (PFAS) are a broad class of synthetic chemicals; some are present in most humans in developed countries. Some studies suggest that certain PFAS may have immunotoxic effects in humans, which could put individuals with high levels of exposure at increased risk for infectious diseases such as COVID-19. We conducted a case-control study to examine the association between COVID-19 diagnosis and PFAS serum concentrations among employees and retirees from two 3 M facilities, one of which historically generated perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), and perfluorohexane sulfonic acid (PFHxS). Participants completed enrollment and follow-up study visits in the Spring of 2021. Participants were categorized as cases if they reported a COVID-19 diagnosis or became sick with at least one symptom of COVID-19 when someone else in their household was diagnosed, otherwise they were categorized as a control. COVID-19 diagnosis was modeled in relation to concentration of serum PFAS measured at enrollment after adjusting for covariates. The analytic sample comprised 573 individuals, 111 cases (19.4%) and 462 controls (80.6%). In adjusted models, the odds ratio of COVID-19 was 0.94 per interquartile range (14.3 ng/mL) increase in PFOS (95% confidence interval 0.85, 1.04). Results for PFOA, PFHxS, and perfluorononanoic acid (PFNA) were similar. Other PFAS present at lower concentrations were examined as categorical variables (above the limit of quantification [LOQ], yes vs. no [referent category]), and also showed no positive associations. In our study, which used individual-level data and included people with high occupational exposure, the serum concentrations of all PFAS examined were not associated with an increased odds ratio for COVID-19. At this point, the epidemiologic data supporting no association of COVID-19 occurrence with PFAS exposure are stronger than those suggesting a positive association.

全氟烷基和多氟烷基物质(PFAS)是一类广泛的合成化学品;发达国家的大多数人体内都含有其中的一些物质。一些研究表明,某些 PFAS 可能会对人体产生免疫毒性作用,这可能会增加高浓度接触者罹患 COVID-19 等传染性疾病的风险。我们进行了一项病例对照研究,考察了来自两家 3 M 工厂的员工和退休人员的 COVID-19 诊断与 PFAS 血清浓度之间的关系,其中一家工厂历史上曾生产过全氟辛酸 (PFOA)、全氟辛烷磺酸 (PFOS) 和全氟己烷磺酸 (PFHxS)。参与者在 2021 年春季完成了注册和后续研究访问。如果参与者报告确诊了 COVID-19,或在家中有人确诊时出现至少一种 COVID-19 症状,则将其归类为病例,否则将其归类为对照。COVID-19 诊断与入组时测量的血清 PFAS 浓度之间的关系是根据协变量调整后建立的模型。分析样本包括 573 人,其中 111 人为病例(19.4%),462 人为对照组(80.6%)。在调整后的模型中,PFOS 每增加 14.3 纳克/毫升,COVID-19 的几率比为 0.94(95% 置信区间为 0.85,1.04)。PFOA、PFHxS和全氟壬酸(PFNA)的结果类似。浓度较低的其他全氟辛烷磺酸作为分类变量(高于定量限 [LOQ],是与否 [参考类别])进行了研究,结果也没有显示出正相关性。我们的研究使用了个人层面的数据,其中包括职业暴露程度较高的人群,在我们的研究中,所有受检全氟辛烷磺酸的血清浓度都与 COVID-19 的几率增加无关。在这一点上,支持 COVID-19 发生与 PFAS 暴露无关的流行病学数据要强于支持正相关的数据。
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引用次数: 0
Global prevalence of vasovagal syncope: A systematic review and meta-analysis 血管迷走性晕厥的全球发病率:系统回顾和荟萃分析
Pub Date : 2024-01-06 DOI: 10.1016/j.gloepi.2024.100136
Nader Salari , Zohre Karimi , Mahvan Hemmati , Ali Mohammadi , Shamarina Shohaimi , Masoud Mohammadi

Background

Today, vasovagal syncope is a common problem that has become a significant health and social challenge. The present study investigated the global prevalence of vasovagal syncope using a systematic review and meta-analysis.

Methods: In this systematic review and meta-analysis study, the global prevalence of vasovagal syncope using the keywords Prevalence, Epidemiology, Vasovagal syncope, and Reflex syncope in PubMed, WoS, Scopus, ScienceDirect databases, and Google scholar search engine without time limit until July 20, 2022, was extracted and transferred to the information management software (EndNote). Then the repeated studies were excluded, and researchers evaluated the remaining studies during three stages (i.e., screening, eligibility, and qualitative assessment). The heterogeneity of studies was investigated using the I2 index, and the analysis of eligible studies was performed using the random effects model.

Results

In the review of 12 studies with a sample size of 36,156 people, the global prevalence of vasovagal syncope was reported as 16.4 (95%CI: 6–37.5), and the study of publication bias in the studies through the Egger test shows the absence of publication bias in the studies.

Conclusion

The prevalence reported in the studies shows a high prevalence of vasovagal syncope, which requires serious intervention and preventive, diagnostic, and therapeutic measures. It is necessary for health policymakers to take effective measures in this field.

背景如今,血管迷走性晕厥是一个常见问题,已成为一项重大的健康和社会挑战。本研究采用系统综述和荟萃分析法调查了血管迷走性晕厥的全球患病率:在这项系统综述和荟萃分析研究中,以Prevalence、Epidemiology、Vasovagal syncope和Reflex syncope为关键词,在PubMed、WoS、Scopus、ScienceDirect数据库和Google scholar搜索引擎中提取了截至2022年7月20日的全球血管迷走性晕厥患病率,并将其转入信息管理软件(EndNote)。然后排除重复研究,研究人员分三个阶段(即筛选、资格审查和定性评估)对剩余研究进行评估。结果在对样本量为 36156 人的 12 项研究的综述中,血管迷走性晕厥的全球患病率为 16.4(95%CI:6-37.结论研究报告的患病率表明,血管迷走性晕厥的患病率很高,需要认真干预并采取预防、诊断和治疗措施。卫生决策者有必要在这一领域采取有效措施。
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引用次数: 0
Seroconversion among children with HBsAg-positive mothers in Indonesia and factors affecting the anti-HBs titers 印度尼西亚母亲为 HBsAg 阳性的儿童的血清转换及影响抗 HBs 滴度的因素
Pub Date : 2024-01-05 DOI: 10.1016/j.gloepi.2024.100135
Angga Wirahmadi, Hartono Gunardi, Bernie Endyarni Medise, Hanifah Oswari, Teny Tjitra Sari, Nastiti Kaswandani, Mulya Rahma Karyanti

Background and aim

Around 2% of newborns are at risk of hepatitis B virus (HBV) infection from their mothers. To prevent this, infants born to HBsAg-positive mothers are given hepatitis B immune globulin (HBIG) and hepatitis B (HB) vaccine as immunoprophylaxis. This study aims to investigate the efficacy of immunoprophylaxis in infants born to HBsAg-positive mothers and the contributing factors.

Methods

The study was conducted on a group of 87 children, ranging from nine months to under 36 months, born to HBsAg-positive mothers and received immunoprophylaxis within 24 h after birth followed by a national immunization schedule at the Community Health Center (CHC) in three administrative cities of DKI Jakarta. We measured the levels of HBsAg and anti-HBs, and utilized ordinal logistic regression models to identify factors that influence the anti-HBs titers after vaccination.

Results

Out of 87 children, only one child had positive HBsAg results. The data showed that 88.5% of the children had seroprotection with anti-HBs levels ≥10 mIU/mL. Additionally, 48.3% of the children had a high protective response with anti-HBs levels ≥100 mIU/mL, while 11.5% had a non-protective response. Children under one year of age, with a family history of HBV carriers, and who received five doses of the HB vaccine exhibited higher levels of anti-HBs titer category with adjusted OR 3.9 (95%CI: 1.3–11.6), 5.3 (95%CI: 1.1–27.4), and 8.3 (95%CI: 2–34.8), respectively.

Conclusion

The administration of HBIG and HB vaccine successfully prevented vertical transmission, resulting in a high seroprotection rate.

背景和目的约有 2% 的新生儿有从母亲处感染乙型肝炎病毒 (HBV) 的风险。为了预防这种情况,HBsAg 阳性母亲所生的婴儿会注射乙型肝炎免疫球蛋白(HBIG)和乙型肝炎(HB)疫苗作为免疫预防。本研究旨在调查 HBsAg 阳性母亲所生婴儿的免疫预防疗效及其诱发因素。研究对象为 87 名婴儿,年龄从 9 个月到不足 36 个月不等,均由 HBsAg 阳性母亲所生,并在出生后 24 小时内接受免疫预防,随后在雅加达 DKI 三个行政城市的社区卫生中心(CHC)按照国家免疫计划接受免疫预防。我们测量了HBsAg和抗-HBs的水平,并利用序数逻辑回归模型确定了影响疫苗接种后抗-HBs滴度的因素。数据显示,88.5%的儿童获得了血清保护,抗-HBs水平≥10 mIU/mL。此外,48.3%的儿童具有高保护性反应,抗-HBs水平≥100 mIU/mL,而11.5%的儿童无保护性反应。一岁以下、有 HBV 携带者家族史和接种过五次 HB 疫苗的儿童的抗 HBs 滴度水平较高,调整后 OR 值分别为 3.9(95%CI:1.3-11.6)、5.3(95%CI:1.1-27.4)和 8.3(95%CI:2-34.8)。
{"title":"Seroconversion among children with HBsAg-positive mothers in Indonesia and factors affecting the anti-HBs titers","authors":"Angga Wirahmadi,&nbsp;Hartono Gunardi,&nbsp;Bernie Endyarni Medise,&nbsp;Hanifah Oswari,&nbsp;Teny Tjitra Sari,&nbsp;Nastiti Kaswandani,&nbsp;Mulya Rahma Karyanti","doi":"10.1016/j.gloepi.2024.100135","DOIUrl":"10.1016/j.gloepi.2024.100135","url":null,"abstract":"<div><h3>Background and aim</h3><p>Around 2% of newborns are at risk of hepatitis B virus (HBV) infection from their mothers. To prevent this, infants born to HBsAg-positive mothers are given hepatitis B immune globulin (HBIG) and hepatitis B (HB) vaccine as immunoprophylaxis. This study aims to investigate the efficacy of immunoprophylaxis in infants born to HBsAg-positive mothers and the contributing factors.</p></div><div><h3>Methods</h3><p>The study was conducted on a group of 87 children, ranging from nine months to under 36 months, born to HBsAg-positive mothers and received immunoprophylaxis within 24 h after birth followed by a national immunization schedule at the Community Health Center (CHC) in three administrative cities of DKI Jakarta. We measured the levels of HBsAg and anti-HBs, and utilized ordinal logistic regression models to identify factors that influence the anti-HBs titers after vaccination.</p></div><div><h3>Results</h3><p>Out of 87 children, only one child had positive HBsAg results. The data showed that 88.5% of the children had seroprotection with anti-HBs levels ≥10 mIU/mL. Additionally, 48.3% of the children had a high protective response with anti-HBs levels ≥100 mIU/mL, while 11.5% had a non-protective response. Children under one year of age, with a family history of HBV carriers, and who received five doses of the HB vaccine exhibited higher levels of anti-HBs titer category with adjusted OR 3.9 (95%CI: 1.3–11.6), 5.3 (95%CI: 1.1–27.4), and 8.3 (95%CI: 2–34.8), respectively.</p></div><div><h3>Conclusion</h3><p>The administration of HBIG and HB vaccine successfully prevented vertical transmission, resulting in a high seroprotection rate.</p></div>","PeriodicalId":36311,"journal":{"name":"Global Epidemiology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590113324000014/pdfft?md5=e7ff2f7fcae161d0e32ff0000d0679f6&pid=1-s2.0-S2590113324000014-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139395507","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Improved clinical trial race/ethnicity reporting and updated inclusion profile, 2017–2022: A New Jersey snapshot 2017-2022 年临床试验种族/族裔报告的改进和纳入概况的更新:新泽西州快照
Pub Date : 2023-12-23 DOI: 10.1016/j.gloepi.2023.100134
Elli Gourna Paleoudis , Zhiyong Han , Simon Gelman , Hernan Arias-Ruiz , Destiney Carter , Jovan Bertrand , Nicole Mastrogiovanni , Stanley R. Terlecky

Background

Diverse representation in clinical trials is an important goal in the testing of a medical, diagnostic, or therapeutic intervention. To date, the desired level of trial equity and inclusivity has been unevenly achieved.

Methods

Employing the US National Library of Medicine's Clinicaltrials.gov registry, we examined 481 clinical trials conducted - at least in part - in the state of New Jersey. These trials were initiated after the FDA-mandated Common Rule changes, i.e., between January 2017 and October 2022, were enacted, and had their results posted. We analyzed sex/race/ethnicity reporting as well as applicable enrollment. Using meta-analysis, we estimated group participation proportions of a subset of the 481 identified trials; specifically, the 229 studies that were conducted solely within the US (i.e., without international sites) and compared them to US census data.

Findings

Within the 481 clinical trials analyzed, over 97% reported on the race and/or ethnicity of their enrollees; all included information on sex. Reporting was not affected by funding source or therapeutic area. Based on the 229 solely US-based studies, the participants overall were 76.7% White; 14.1% Black; 2.7% Asian; and 15% Hispanic. Inclusion of Black participants did not differ from the 2020 US census data; in contrast, the levels of Asian and Hispanic participation were below the corresponding census percentages.

Interpretation

The past five years have seen an overall uptick in the equity of race/ethnicity reporting and inclusivity of clinical trials, as compared to previously reported data, presaging the potential acquisition of ever more powerful and meaningful results of such interventional studies going forward.

Funding

Support for this study comes from the Hackensack Meridian Health Research Institute and the Hackensack Meridian School of Medicine.

Research in context

Evidence before this study

Clinical trials are a critical part of determining whether or not a medical (drug/device/biologic) or socio-behavioral intervention is safe and truly effective. Through their use, scientific understanding is advanced and, ideally, human health is improved. To gain the most impactful information from a clinical trial, it should be sufficiently representative, that is, should enroll an adequate number of participants, and include a diverse population. Without such inclusion, the study is of only limited generalizability. Efforts are underway by funders, sites, and other stakeholders, to enhance reporting and promote inclusive enrollment. The extent to which such attempts are yielding results - at least for clinical trials in the state of New Jersey - is the focus of this data-driven analysis. The ClinicalTrials.gov registry databa

背景临床试验中的多元化代表是测试医疗、诊断或治疗干预措施的一个重要目标。方法利用美国国家医学图书馆的 Clinicaltrials.gov 注册表,我们研究了在新泽西州进行的 481 项临床试验(至少有一部分是在新泽西州进行的)。这些试验都是在 FDA 规定的共同规则变更(即 2017 年 1 月至 2022 年 10 月期间)颁布后启动的,并公布了结果。我们分析了性别/种族/人种报告以及适用的注册情况。通过荟萃分析,我们估算了 481 项已确定试验中一部分试验的群体参与比例,特别是仅在美国境内进行的 229 项研究(即不包括国际试验点),并将其与美国人口普查数据进行了比较。研究结果在所分析的 481 项临床试验中,97% 以上的试验报告了参与试验者的种族和/或民族情况;所有试验都包含性别信息。报告不受资金来源或治疗领域的影响。在 229 项仅基于美国的研究中,参与者总体为 76.7% 白人、14.1% 黑人、2.7% 亚洲人和 15% 西班牙裔人。黑人参与者的纳入情况与 2020 年美国人口普查数据没有差异;相比之下,亚裔和西班牙裔参与者的参与水平低于相应的人口普查百分比。释义与之前报告的数据相比,过去五年中临床试验的种族/民族报告公平性和包容性总体上有所提高,这预示着此类干预性研究今后可能会获得更有力、更有意义的结果。研究背景本研究之前的证据临床试验是确定医疗(药物/器械/生物)或社会行为干预是否安全和真正有效的关键部分。通过使用临床试验,可以促进对科学的理解,并在理想情况下改善人类健康。为了从临床试验中获得最有影响力的信息,临床试验应具有充分的代表性,即应招募足够数量的参与者,并纳入不同的人群。如果没有足够的代表性,研究的普遍性就很有限。资助方、研究机构和其他利益相关方正在努力加强报告工作,促进包容性入组。至少对于新泽西州的临床试验而言,这些尝试在多大程度上取得了成果,是本数据驱动分析的重点。我们对在新泽西州启动并在该州或美国其他地区进行的临床试验进行了分析,发现了一些积极的趋势。我们的五年快照显示,有很大比例的试验报告了种族/族裔情况,包容性正在提高。虽然要使这些试验中的人口统计数字与美国人口普查值相匹配还有一段路要走,但我们的结果表明,最近的努力正在产生效果。在很多方面,医学的发展与信任息息相关--没有信任,现代医疗保健的承诺就会受到质疑。临床试验必须包括对多样化入组和依法公平报告的承诺。通过提高临床试验的包容性和结果报告的透明度来创造信任的遗产,将开始弥合分歧,并使人们对现代医学和当今的医疗保健系统充满信心。同时,这也将使临床试验结果在不同患者群体中具有深远的推广意义。为了更好地了解未来需要做什么,我们必须真正了解临床试验报告和人口统计学纳入的现状。本报告通过仔细记录新泽西州临床试验的执行情况,开始了这样的分析。由于其地理位置(如毗邻纽约和费城),新泽西州是大型生物制药集群和医疗保健中心的一部分;因此,新泽西州在采用/遵守最新临床试验指南规定方面的表现至关重要。本报告提供了从 2017 年到 2022 年新泽西州临床试验状况的一瞥--重要的初探。
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引用次数: 0
期刊
Global Epidemiology
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