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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
Differences in SARS-COV-2 seroprevalence in the population of Cusco, Peru 秘鲁库斯科人口中 SARS-COV-2 血清流行率的差异
Pub Date : 2023-12-17 DOI: 10.1016/j.gloepi.2023.100131
Huamaní Charles , Concha-Velasco Fátima , Velásquez Lucio , K. Antich María , Cassa Johar , Palacios Kevin , Bernable-Villasante Luz , Giraldo-Alencastre Guido , Benites-Calderon Eduarda , Mendieta-Nuñez Sebastian , Quispe-Jihuallanca Heber , Quispe-Yana Matilde , Zavala-Vargas Karla , Hinojosa-Florez Liesbeth , Ramírez-Escobar Javier , Spelucin-Runciman Juan , Bernabe-Ortiz Antonio

Background

The spread of the coronavirus disease 2019 (COVID-19) in Peru has been reported at the regional level, few studies have evaluated its spread at the provincial level, in which the mechanisms could be different.

Methods

We conducted an analytical, cross-sectional, multistage observational population study to assess the seroprevalence of SARS-COV-2 at the provincial and urban/rural levels in a high-altitude setting. The sampling unit was the household, including a randomly selected family member. Sampling was performed using a data collection sheet on clinical and epidemiological variables. Chemiluminescence tests were used to detect total anti-SARS-COV-2 antibodies (IgG and IgM simultaneously). The percentages were adjusted to the sampling design.

Results

The overall prevalence in the region of Cusco was 25.9%, with considerably different prevalence between the 13 provinces (from 15.9% in Acomayo to 40.1% in Canchis) and between rural (21.1%) and urban (31.7%) areas. In multivariable model, living in a rural area was a protective factor (adjusted prevalence ratio [aPR], 0.68; 95% confidence interval [CI], 0.61–0.76).

Conclusions

Geographic diversity and population density determine different prevalence rates, typically lower in rural areas, possibly due to natural social distancing or limited interaction with people at risk.

方法我们进行了一项分析性、横断面、多阶段观察性人口研究,以评估高海拔地区省和城乡两级的 SARS-COV-2 血清流行率。抽样单位为家庭,包括随机抽取的一名家庭成员。采样时使用了临床和流行病学变量数据收集表。化学发光试验用于检测抗 SARS-COV-2 总抗体(IgG 和 IgM 同时检测)。结果库斯科地区的总患病率为 25.9%,13 个省(从阿科马约省的 15.9% 到坎奇斯省的 40.1%)之间以及农村(21.1%)和城市(31.7%)之间的患病率差异很大。在多变量模型中,居住在农村地区是一个保护性因素(调整患病率比[aPR],0.68;95%置信区间[CI],0.61-0.76)。
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引用次数: 0
An AI assistant to help review and improve causal reasoning in epidemiological documents 帮助审查和改进流行病学文件中因果推理的人工智能助手
Pub Date : 2023-12-04 DOI: 10.1016/j.gloepi.2023.100130
Louis Anthony Cox Jr.

Drawing sound causal inferences from observational data is often challenging for both authors and reviewers. This paper discusses the design and application of an Artificial Intelligence Causal Research Assistant (AIA) that seeks to help authors improve causal inferences and conclusions drawn from epidemiological data in health risk assessments. The AIA-assisted review process provides structured reviews and recommendations for improving the causal reasoning, analyses and interpretations made in scientific papers based on epidemiological data. Causal analysis methodologies range from earlier Bradford-Hill considerations to current causal directed acyclic graph (DAG) and related models. AIA seeks to make these methods more accessible and useful to researchers. AIA uses an external script (a “Causal AI Booster” (CAB) program based on classical AI concepts of slot-filling in frames organized into task hierarchies to complete goals) to guide Large Language Models (LLMs), such as OpenAI's ChatGPT or Google's LaMDA (Bard), to systematically review manuscripts and create both (a) recommendations for what to do to improve analyses and reporting; and (b) explanations and support for the recommendations. Review tables and summaries are completed systematically by the LLM in order. For example, recommendations for how to state and caveat causal conclusions in the Abstract and Discussion sections reflect previous analyses of the Study Design and Data Analysis sections. This work illustrates how current AI can contribute to reviewing and providing constructive feedback on research documents. We believe that such AI-assisted review shows promise for enhancing the quality of causal reasoning and exposition in epidemiological studies. It suggests the potential for effective human-AI collaboration in scientific authoring and review processes.

从观察数据中得出合理的因果推论对作者和审稿人来说往往都具有挑战性。本文讨论了人工智能因果研究助手(AIA)的设计和应用,该助手旨在帮助作者改进健康风险评估中从流行病学数据中得出的因果推论和结论。人工智能因果研究助手(AIA)的辅助审查过程提供结构化审查和建议,以改进基于流行病学数据的科学论文中的因果推理、分析和解释。因果分析方法从早期的布拉德福德-希尔(Bradford-Hill)考虑到目前的因果有向无环图(DAG)和相关模型。AIA 试图让研究人员更容易使用这些方法,并使其更加有用。AIA 使用外部脚本(基于经典人工智能概念的 "因果人工智能助推器"(CAB)程序,即在按任务分层组织的框架中填槽,以完成目标)来指导大型语言模型(LLM),如 OpenAI 的 ChatGPT 或 Google 的 LaMDA (Bard),以系统地审阅手稿,并创建(a)关于如何改进分析和报告的建议;以及(b)对建议的解释和支持。审稿表和摘要由法律硕士按顺序系统完成。例如,关于如何在摘要和讨论部分陈述因果关系结论并加以说明的建议反映了之前对研究设计和数据分析部分的分析。这项工作说明了当前的人工智能如何能为审核研究文件并提供建设性反馈做出贡献。我们相信,这种人工智能辅助审阅有望提高流行病学研究中因果推理和论述的质量。它表明,在科学著作和评审过程中,人类与人工智能有可能进行有效合作。
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引用次数: 0
Does adjustment for non-differential misclassification of dichotomous exposure induce positive bias if there is no true association? 如果不存在真正的关联,对二分暴露的非差异性误分类进行调整是否会引起正偏差?
Pub Date : 2023-12-03 DOI: 10.1016/j.gloepi.2023.100132
Igor Burstyn

This article is a response to an off-the-record discussion that I had at an international meeting of epidemiologists more than decade ago. It centered on a concern, perhaps widely spread, that adjustment for exposure misclassification can induce a false positive result. I trace the possible history of this supposition and test it in a simulated case-control study under the assumption of non-differential misclassification of binary exposure, in which a Bayesian adjustment is applied. Probabilistic bias analysis is also briefly considered. The main conclusion is that adjustment for the presumed non-differential exposure misclassification of dichotomous does not “induce” positive associations, especially if the focus of the interpretation of the result is taken away from the point estimate. The misconception about positive bias induced by adjustment for exposure misclassification, if more clearly explained during the training of epidemiologists, may promote appropriate (and wider) use of the adjustment techniques. The simple message that can be derived from this paper is: “Exposure misclassification as a tractable problem that deserves much more attention than just a typical qualitative throw-away discussion”.

这篇文章是对我十多年前在一次国际流行病学家会议上的一次非正式讨论的回应。讨论的焦点是一种可能广为流传的担忧,即对暴露误分类的调整可能会导致假阳性结果。我追溯了这一假设的可能历史,并在一项模拟病例对照研究中对其进行了检验,该研究假定二元暴露无差别误分类,并应用了贝叶斯调整法。此外,还简要考虑了概率偏差分析。主要结论是,对假定的非差异性二元暴露误分类进行调整并不会 "诱发 "正相关,特别是如果对结果的解释重点脱离了点估计。如果在对流行病学家进行培训时能更清楚地解释对暴露误分类进行调整所引起的正偏倚这一误解,可能会促进调整技术的适当(和更广泛)使用。从这篇论文中我们可以得到一个简单的信息:"暴露误分类是一个可以解决的问题,值得更多的关注,而不仅仅是一个典型的定性讨论"。
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引用次数: 0
Wildfire and child displacement: Still a burning issue 野火和儿童流离失所:仍然是一个亟待解决的问题
Pub Date : 2023-11-17 DOI: 10.1016/j.gloepi.2023.100127
Sachin C. Sarode , Namdeo J. Pawar , Gargi Sarode , Shruti Singh
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引用次数: 0
Air pollution accountability research: Moving from a chain to a web 空气污染责任研究:从链条到网络
Pub Date : 2023-11-15 DOI: 10.1016/j.gloepi.2023.100128
S. Ebelt , L. Baxter , H.S. Erickson , L.R.F. Henneman , S. Lange , T.J. Luben , M. Neidell , A.M. Rule , A.G. Russell , J. Wendt Hess , C.J. Burns , J.S. LaKind , J.E. Goodman

Air pollution accountability studies examine the relationship(s) between an intervention, regulation, or event and the resulting downstream impacts, if any, on emissions, exposure, and/or health. The sequence of events has been schematically described as an accountability chain. Here, we update the existing framework to capture real-life complexities and to highlight important factors that fall outside the linear chain. This new “accountability web” is intended to convey the intricacies associated with conducting an accountability study to various audiences, including researchers, policy makers, and stakeholders. We also identify data considerations for planning and completing a robust accountability study, including those relevant to novel and innovative air pollution and exposure data. Finally, we present a series of recommendations for the accountability research community that can serve as a guide for the next generation of accountability studies.

空气污染问责研究检查干预、监管或事件与由此产生的下游影响之间的关系,如果有的话,对排放、暴露和/或健康的影响。事件的顺序已被简略地描述为责任链。在这里,我们更新了现有的框架,以捕捉现实生活中的复杂性,并突出了线性链之外的重要因素。这个新的“问责网络”旨在向包括研究人员、政策制定者和利益相关者在内的各种受众传达与进行问责研究相关的复杂性。我们还确定了规划和完成强有力的问责研究的数据考虑因素,包括与新颖和创新的空气污染和暴露数据相关的数据。最后,我们为问责研究界提出了一系列建议,可以作为下一代问责研究的指南。
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引用次数: 0
Commentary: On measurement error, PSA doubling time, and prostate cancer 评论:关于测量误差,PSA倍增时间,和前列腺癌
Pub Date : 2023-11-14 DOI: 10.1016/j.gloepi.2023.100129
Lawrence L. Kupper , Sandra L. Martin , Christopher J. Wretman

Exposure measurement error is a pervasive problem for epidemiology research projects designed to provide valid and precise statistical evidence supporting postulated exposure-disease relationships of interest. The purpose of this commentary is to highlight an important real-life example of this exposure measurement error problem and to provide a simple and useful diagnostic tool for physicians and their patients that corrects for the exposure measurement error. More specifically, prostate-specific antigen doubling time (PSADT) is a widely used measure for guiding future treatment options for patients with biochemically recurrent prostate cancer. Numerous papers have been published claiming that a low calculated PSADT value (denoted PSADT̂) is predictive of metastasis and premature death from prostate cancer. Unfortunately, none of these papers have adjusted for the measurement error in PSADT̂, an estimator that is typically computed using the popular Memorial Sloan Kettering website very often visited by both physicians and their patients. For this website, the estimator PSADT̂ of the true (but unknown) PSADT for a patient (denoted PSADT) is computed as the natural log of 2 (i.e., 0.6931) divided by the estimated slope of the straight-line regression of the natural log of PSA (in ng/mL) on time. We utilize PSADT̂ to derive an expression for the probability that the unknown PSADT for a patient is below a specified value C (>0) of concern to both the physician and the patient. This probability is easy to interpret and takes into account the fact that PSADT̂ is a statistical estimator with variability. This variability introduces measurement error, namely, the difference between a computed value PSADT̂ and the true, but unknown, value PSADT. We have developed an Excel calculator that, once the [time, ln(PSA)] values are entered, outputs both the value of PSADT̂ and the desired probability. In addition, we discuss problematic statistical issues attendant with PSADT estimation typically based on at most three or four PSA values. We strongly recommend the use of this probability when physicians are discussing PSADT̂ values and associated treatment options with their patients. And, we stress that future epidemiology research projects involving PSA doubling time should take into account the measurement error problem highlighted in this Comment

对于流行病学研究项目来说,暴露测量误差是一个普遍存在的问题,流行病学研究项目旨在提供有效和精确的统计证据来支持感兴趣的假定暴露-疾病关系。这篇评论的目的是强调这个暴露测量误差问题的一个重要的现实例子,并为医生和他们的病人提供一个简单而有用的诊断工具来纠正暴露测量误差。更具体地说,前列腺特异性抗原倍增时间(PSADT)是一种广泛使用的指标,用于指导生化复发前列腺癌患者未来的治疗选择。已发表的许多论文声称,低计算的PSADT值(表示PSADT³)可预测前列腺癌的转移和过早死亡。不幸的是,这些论文都没有对PSADT的测量误差进行调整,PSADT是一个估计量,通常是通过医生和病人经常访问的流行的Memorial Sloan Kettering网站来计算的。对于本网站,患者真实(但未知)PSADT(记为PSADT *)的估计量PSADT³计算为2的自然对数(即0.6931)除以PSA(以ng/mL为单位)自然对数随时间的直线回归的估计斜率。我们利用PSADT³来推导出患者的未知PSADT *低于医生和患者都关心的规定值C(>0)的概率表达式。这个概率很容易解释,并且考虑到PSADT³是一个具有可变性的统计估计量。这种可变性引入了测量误差,即计算值PSADT³与真实但未知的值PSADT *之间的差异。我们开发了一个Excel计算器,一旦输入[时间,ln(PSA)]值,就会输出PSADT的值和期望的概率。此外,我们还讨论了通常最多基于三个或四个PSA值的PSADT *估计所伴随的有问题的统计问题。我们强烈建议医生在与患者讨论PSADT值和相关治疗方案时使用该概率。并且,我们强调,未来涉及PSA加倍时间的流行病学研究项目应考虑到本评论中强调的测量误差问题。
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引用次数: 0
Post-COVID-19 syndrome: Descriptive analysis based on a survivors' cohort in Colombia covid -19后综合征:基于哥伦比亚幸存者队列的描述性分析
Pub Date : 2023-10-27 DOI: 10.1016/j.gloepi.2023.100126
Martin Romero , Martha Caicedo , Andrea Díaz , Delia Ortega , Claudia Llanos , Alejandro Concha , Andrés Vallejo , Fernando Valdés , César González

Background

The prevalence of post-COVID-19 Syndrome (PCS) is estimated to be between 10% and 20%. The main reported symptoms are fatigue, memory alterations, dyspnea, sleep disorders, arthralgia, anxiety, taste alterations, coughing and depression. This study aims to determine the prevalence of post-COVID-19 symptoms in a group of Colombian patients who were recruited during their outpatient appointments.

Methodology

This cross-sectional study was conducted between December 2021 to May 2022. It included patients from outpatient facilities located in five main cities in Colombia who were positive for SARS-CoV-2 infection detected by reverse transcription-polymerase chain reaction (RT-PCR) testing and reported PCS in the following 12 weeks after their COVID-19 diagnosis.

Results

A total of 1047 individuals >18 years old met the inclusion criteria and were included in the study. The median age was 46 years old. 68.2% of the participants were female, 41.5% of the patients reported having a pre-existent condition (hypertension, anxiety disorder, diabetes, hyperthyroidism, obesity and asthma). Only 22% had received at least one dose of COVID-19 vaccine prior to the COVID-19 episode registered. The more prevalent symptoms within our group are described as follows: fatigue (53.3%), dyspnea (40.3%), arthralgia and/or myalgia (43%), cephalea (40.5%), sleep disorders (35.7%) and coughing (31.3%). 72% of the patients presented four or more post-COVID 19 symptoms, 9% two symptoms, and 10% only one symptom.

Conclusion

The findings of this study are consistent with international literature publicly available. The distribution and prevalence of post-COVID symptoms highlight the importance of further research to improve understanding and its potential consequences and implications in terms of quality of life and health care planning services.

据估计,covid -19后综合征(PCS)的患病率在10%至20%之间。报告的主要症状有疲劳、记忆改变、呼吸困难、睡眠障碍、关节痛、焦虑、味觉改变、咳嗽和抑郁。本研究旨在确定在门诊预约期间招募的一组哥伦比亚患者中covid -19后症状的患病率。本横断面研究于2021年12月至2022年5月进行。该研究包括来自哥伦比亚五个主要城市门诊机构的患者,他们通过逆转录聚合酶链反应(RT-PCR)检测出SARS-CoV-2感染呈阳性,并在诊断出COVID-19后的12周内报告了PCS。结果共有1047名符合纳入标准的18岁成人被纳入研究。平均年龄为46岁。68.2%的参与者为女性,41.5%的患者报告有先前存在的疾病(高血压、焦虑症、糖尿病、甲状腺功能亢进、肥胖和哮喘)。只有22%的人在COVID-19发作前至少接种了一剂COVID-19疫苗。本组更常见的症状如下:疲劳(53.3%)、呼吸困难(40.3%)、关节痛和/或肌痛(43%)、头痛(40.5%)、睡眠障碍(35.7%)和咳嗽(31.3%)。72%的患者出现四种或以上的新冠肺炎后症状,9%出现两种症状,10%只有一种症状。结论本研究结果与国际公开文献一致。covid后症状的分布和流行突出了进一步研究的重要性,以提高对生活质量和卫生保健规划服务的理解及其潜在后果和影响。
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引用次数: 0
Critical concern of tobacco consumption among pregnant and lactating women in India: A call for comprehensive data and intervention strategies 对印度孕妇和哺乳期妇女烟草消费的严重关切:呼吁提供综合数据和干预战略
Pub Date : 2023-10-23 DOI: 10.1016/j.gloepi.2023.100125
Shruti Singh , Gargi Sarode , Rahul Anand , Namrata Sengupta , Sachin C. Sarode
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引用次数: 0
Management of Nipah outbreak in India: A plea for immediate action 印度尼帕疫情的管理:呼吁立即采取行动。
Pub Date : 2023-10-12 DOI: 10.1016/j.gloepi.2023.100123
Poonam Suryawanshi , Sachin Sarode , Srikant Tripathy
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引用次数: 224
期刊
Global Epidemiology
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