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Introduction and rollout of malaria vaccines in Cameroon and Burkina Faso: early lessons learned. 在喀麦隆和布基纳法索引入和推广疟疾疫苗:早期经验教训。
IF 34.3 1区 医学 Q1 Medicine Pub Date : 2024-05-01 DOI: 10.1016/S2214-109X(24)00101-3
Adidja Amani, Franck Mboussou, Benido Impouma, Joseph Cabore, Matshidiso R Moeti
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引用次数: 0
Diabetes and diabetic retinopathy: the growing public health concerns in India. 糖尿病和糖尿病视网膜病变:印度日益严重的公共卫生问题。
IF 34.3 1区 医学 Q1 Medicine Pub Date : 2024-05-01 Epub Date: 2024-02-28 DOI: 10.1016/S2214-109X(24)00075-5
Suraj Singh Senjam
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引用次数: 0
Advancing equity in medical device performance. 促进医疗设备性能的公平性。
IF 34.3 1区 医学 Q1 Medicine Pub Date : 2024-05-01 DOI: 10.1016/S2214-109X(24)00141-4
The Lancet Global Health
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引用次数: 0
National prevalence of vision impairment and blindness and associated risk factors in adults aged 40 years and older with known or undiagnosed diabetes: results from the SMART-India cross-sectional study. 全国 40 岁及以上已知或未确诊糖尿病成人视力损伤和失明的流行率及相关风险因素:SMART-India 横断面研究的结果。
IF 34.3 1区 医学 Q1 Medicine Pub Date : 2024-05-01 Epub Date: 2024-02-28 DOI: 10.1016/S2214-109X(24)00035-4
Sarega Gurudas, Joana C Vasconcelos, A Toby Prevost, Rajiv Raman, Ramachandran Rajalakshmi, Kim Ramasamy, Viswanathan Mohan, Padmaja K Rani, Taraprasad Das, Dolores Conroy, Robyn J Tapp, Sobha Sivaprasad

Background: National estimates of the prevalence of vision impairment and blindness in people with diabetes are required to inform resource allocation. People with diabetes are more susceptible to conditions such as diabetic retinopathy that can impair vision; however, these are often missed in national studies. This study aims to determine the prevalence and risk factors of vision impairment and blindness in people with diabetes in India.

Methods: Data from the SMART-India study, a cross-sectional survey with national coverage of 42 147 Indian adults aged 40 years and older, collected using a complex sampling design, were used to obtain nationally representative estimates for the prevalence of vision impairment and blindness in people with diabetes in India. Vulnerable adults (primarily those who did not have capacity to provide consent); pregnant and breastfeeding women; anyone deemed too ill to be screened; those who did not provide consent; and people with type 1 diabetes, gestational diabetes, or secondary diabetes were excluded from the study. Vision impairment was defined as presenting visual acuity of 0·4 logMAR or higher and blindness as presenting a visual acuity of 1·0 logMAR or higher in the better-seeing eye. Demographic, anthropometric, and laboratory data along with geographic distribution were analysed in all participants with available data. Non-mydriatic retinal images were used to grade diabetic retinopathy, and risk factors were also assessed.

Findings: A total of 7910 people with diabetes were included in the analysis, of whom 5689 had known diabetes and 2221 were undiagnosed. 4387 (55·5%) of 7909 participants with available sex data were female and 3522 (44·5%) participants were male. The estimated national prevalence of vision impairment was 21·1% (95% CI 15·7-27·7) and blindness 2·4% (1·7-3·4). A higher prevalence of any vision impairment (29·2% vs 19·6%; p=0·016) and blindness (6·7% vs 1·6%; p<0·0001) was observed in those with ungradable images. In known diabetes, diabetic retinopathy (adjusted odds ratio [aOR] 3·06 [95% CI 1·25-7·51]), vision-threatening diabetic retinopathy (aOR 7·21 [3·52-14·75]), and diabetic macular oedema (aOR 5·41 [2·20-13·33]) were associated with blindness in adjusted analysis. Common sociodemographic risk factors for vision impairment and blindness include older age, lower educational attainment, and unemployment.

Interpretation: Based on the estimated 101 million people with diabetes in 2021 and the interpretation of the data from this study, approximately 21 million people with diabetes have vision impairment in India, of whom 2·4 million are blind. Higher prevalence is observed in those from lower socio-economic strata and policy makers should focus on these groups to reduce inequalities in health care.

Funding: Global Challenge Research Fund of United Kingdom Research and Innovati

背景:需要对全国糖尿病患者视力受损和失明的发生率进行估算,以便为资源分配提供依据。糖尿病患者更容易患上糖尿病视网膜病变等损害视力的疾病;然而,这些疾病往往被国家研究忽略。本研究旨在确定印度糖尿病患者视力受损和失明的发病率和风险因素:方法:SMART-India 研究是一项横断面调查,覆盖全国 42 147 名 40 岁及以上的印度成年人,采用复杂的抽样设计收集数据,以获得具有全国代表性的印度糖尿病患者视力受损和失明患病率的估计值。弱势成人(主要是那些没有能力提供同意书的人)、孕妇和哺乳期妇女、任何被认为病重无法接受筛查的人、那些没有提供同意书的人、1 型糖尿病患者、妊娠糖尿病患者或继发性糖尿病患者均不在研究范围内。视力受损是指视力在 0-4 logMAR 或以上,失明是指视力较好的那只眼睛视力在 1-0 logMAR 或以上。对所有提供数据的参与者的人口统计学、人体测量学和实验室数据以及地理分布进行了分析。使用非眼球视网膜图像对糖尿病视网膜病变进行分级,并对风险因素进行评估:共有 7910 名糖尿病患者参与了分析,其中 5689 人已知患有糖尿病,2221 人未确诊。在 7909 名有性别数据的参与者中,女性为 4387 人(55-5%),男性为 3522 人(44-5%)。据估计,全国视力受损患病率为 21-1%(95% CI 15-7-27-7),失明患病率为 2-4%(1-7-3-4)。任何视力损伤(29-2% 对 19-6%;p=0-016)和失明(6-7% 对 1-6%;p解释)的患病率均较高:根据 2021 年估计的 1.01 亿糖尿病患者人数和本研究数据的解释,印度约有 2 100 万糖尿病患者视力受损,其中 200-400 万人失明。社会经济地位较低的人群发病率较高,政策制定者应重点关注这些群体,以减少医疗保健中的不平等现象:资金来源:英国医学研究委员会研究与创新全球挑战研究基金。
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引用次数: 0
Elimination of transmission of onchocerciasis (river blindness) with long-term ivermectin mass drug administration with or without vector control in sub-Saharan Africa: a systematic review and meta-analysis. 在撒哈拉以南非洲长期大量使用伊维菌素,同时控制或不控制病媒,消除盘尾丝虫病(河盲症)的传播:系统回顾和荟萃分析。
IF 19.9 1区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-05-01 Epub Date: 2024-03-11 DOI: 10.1016/S2214-109X(24)00043-3
Nyamai Mutono, Maria-Gloria Basáñez, Ananthu James, Wilma A Stolk, Anita Makori, Teresia Njoki Kimani, T Déirdre Hollingsworth, Andreia Vasconcelos, Matthew A Dixon, Sake J de Vlas, S M Thumbi

Background: WHO has proposed elimination of transmission of onchocerciasis (river blindness) by 2030. More than 99% of cases of onchocerciasis are in sub-Saharan Africa. Vector control and mass drug administration of ivermectin have been the main interventions for many years, with varying success. We aimed to identify factors associated with elimination of onchocerciasis transmission in sub-Saharan Africa.

Methods: For this systematic review and meta-analysis we searched for published articles reporting epidemiological or entomological assessments of onchocerciasis transmission status in sub-Saharan Africa, with or without vector control. We searched MEDLINE, PubMed, Web of Science, Embase, Cochrane Central Register of Controlled Trials, African Index Medicus, and Google Scholar databases for all articles published from database inception to Aug 19, 2023, without language restrictions. The search terms used were "onchocerciasis" AND "ivermectin" AND "mass drug administration". The three inclusion criteria were (1) focus or foci located in Africa, (2) reporting of elimination of transmission or at least 10 years of ivermectin mass drug administration in the focus or foci, and (3) inclusion of at least one of the following assessments: microfilarial prevalence, nodule prevalence, Ov16 antibody seroprevalence, and blackfly infectivity prevalence. Epidemiological modelling studies and reviews were excluded. Four reviewers (NM, AJ, AM, and TNK) extracted data in duplicate from the full-text articles using a data extraction tool developed in Excel with columns recording the data of interest to be extracted, and a column where important comments for each study could be highlighted. We did not request any individual-level data from authors. Foci were classified as achieving elimination of transmission, being close to elimination of transmission, or with ongoing transmission. We used mixed-effects meta-regression models to identify factors associated with transmission status. This study is registered in PROSPERO, CRD42022338986.

Findings: Of 1525 articles screened after the removal of duplicates, 75 provided 282 records from 238 distinct foci in 19 (70%) of the 27 onchocerciasis-endemic countries in sub-Saharan Africa. Elimination of transmission was reported in 24 (9%) records, being close to elimination of transmission in 86 (30%) records, and ongoing transmission in 172 (61%) records. I2 was 83·3% (95% CI 79·7 to 86·3). Records reporting 10 or more years of continuous mass drug administration with 80% or more therapeutic coverage of the eligible population yielded significantly higher odds of achieving elimination of transmission (log-odds 8·5 [95% CI 3·5 to 13·5]) or elimination and being close to elimination of transmission (42·4 [18·7 to 66·1]) than those with no years achieving 80% coverage or more. Reporting 15-19 years of ivermectin mass drug administration (22·7 [17·2 t

背景:世卫组织提出到 2030 年消除盘尾丝虫病(河盲症)的传播。99%以上的盘尾丝虫病病例发生在撒哈拉以南非洲地区。多年来,病媒控制和大规模使用伊维菌素一直是主要的干预措施,但取得的成效各不相同。我们旨在确定与消除撒哈拉以南非洲盘尾丝虫病传播相关的因素:在这一系统综述和荟萃分析中,我们搜索了已发表的文章,这些文章报告了撒哈拉以南非洲地区盘尾丝虫病传播状况的流行病学或昆虫学评估,无论是否进行了病媒控制。我们在 MEDLINE、PubMed、Web of Science、Embase、Cochrane Central Register of Controlled Trials、African Index Medicus 和 Google Scholar 数据库中检索了从数据库建立到 2023 年 8 月 19 日发表的所有文章,没有语言限制。使用的检索词为 "盘尾丝虫病"、"伊维菌素 "和 "大规模给药"。三个纳入标准是:(1)病灶或病区位于非洲;(2)报告在病灶或病区消除传播或至少 10 年伊维菌素大规模用药;(3)至少纳入以下一项评估:微丝蚴流行率、结节流行率、Ov16 抗体血清流行率和黑蝇感染率。流行病学模型研究和综述被排除在外。四位审稿人(NM、AJ、AM 和 TNK)使用 Excel 中开发的数据提取工具从全文文章中提取一式两份的数据,该工具的各栏记录了要提取的相关数据,还有一栏用于强调每项研究的重要评论。我们没有要求作者提供任何个人层面的数据。病灶被分为已消除传播、接近消除传播或仍在传播。我们使用混合效应元回归模型来确定与传播状况相关的因素。本研究已在 PROSPERO 注册,编号为 CRD42022338986:在剔除重复文章后筛选出的 1525 篇文章中,有 75 篇提供了来自撒哈拉以南非洲 27 个盘尾丝虫病流行国家中 19 个国家(70%)238 个不同病灶的 282 条记录。有 24 条(9%)记录报告已消除传播,86 条(30%)记录报告接近消除传播,172 条(61%)记录报告仍在传播。I2 为 83-3%(95% CI 79-7 至 86-3)。报告连续大规模用药 10 年或更长时间,治疗覆盖率达到或超过 80% 的合格人群的记录中,实现消除传播(对数 8-5 [95% CI 3-5 至 13-5])或消除并接近消除传播(42-4 [18-7 至 66-1])的几率明显高于没有达到或超过 80% 治疗覆盖率的记录。报告伊维菌素大规模用药 15-19 年(22-7 [17-2 至 28-2])和一年两次用药(43-3 [27-2 至 59-3])分别与消灭和接近消灭传播正相关,而报告伊维菌素大规模用药少于 15 年和一年两次用药分别与消灭和接近消灭传播正相关。与未进行病媒控制和低度流行相比,进行过病媒控制但未消灭病媒(-42-8 [-59-1 to -26-5])和基线全流行(-41-97 [-60-6 to -23-2])分别与持续传播的风险增加有关。病媒控制或环境变化导致的黑蝇消失有助于消除传播:大规模用药的持续时间、频率和覆盖范围;基线流行率;以及病媒的消灭或消失是在撒哈拉以南非洲消除盘尾丝虫病传播的重要决定因素。我们的研究结果强调,如果各国要实现消除盘尾丝虫病传播,就必须提高并维持高治疗覆盖率,增加治疗频率:比尔及梅琳达-盖茨基金会、被忽视热带病建模联合会、英国医学研究理事会和全球健康 EDCTP3 联合项目:摘要的斯瓦希里语、法语、西班牙语和葡萄牙语译文见补充材料部分。
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引用次数: 0
Global brain health-the time to act is now. 全球大脑健康--现在就行动起来。
IF 34.3 1区 医学 Q1 Medicine Pub Date : 2024-05-01 Epub Date: 2024-03-14 DOI: 10.1016/S2214-109X(23)00602-2
Andrea S Winkler, Saksham Gupta, Vikram Patel, Arnold Bhebhe, Agnès Fleury, Camilla G Aukrust, Tarun Dua, Tamara M Welte, Sarbani Chakraborty, Kee B Park
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引用次数: 0
Cooking with liquefied petroleum gas or biomass and fetal growth outcomes: a multi-country randomised controlled trial 用液化石油气或生物质做饭与胎儿生长结果:多国随机对照试验
IF 34.3 1区 医学 Q1 Medicine Pub Date : 2024-04-11 DOI: 10.1016/s2214-109x(24)00033-0
William Checkley MD, Lisa M Thompson PhD, Shakir Hossen MBBS, Laura Nicolaou PhD, Kendra N Williams PhD, Stella M Hartinger PhD, Marilu Chiang MD, Kalpana Balakrishnan PhD, Sarada S Garg DNB, Gurusamy Thangavel MSc, Vigneswari Aravindalochanan PhD, Ghislaine Rosa PhD, Alexie Mukeshimana Adv Dip, Florien Ndagijimana MPH, John P McCracken ScD, Anaité Diaz-Artiga MPH, Sheela S Sinharoy PhD, Lance Waller PhD, Jiantong Wang MS, Shirin Jabbarzadeh MD, Yunyun Chen MSPH, Kyle Steenland PhD, Miles A Kirby PhD, Usha Ramakrishnan PhD, Michael Johnson PhD, Ajay Pillarisetti PhD, Eric D McCollum MD, Rachel Craik BSc, Eric O Ohuma PhD, Victor G Dávila-Román MD, Lisa de las Fuentes MD, Suzanne M Simkovich MD, Jennifer L Peel PhD, Thomas F Clasen PhD, Aris T Papageorghiou MD, Household Air Pollution Intervention Network (HAPIN) Investigators, Gloriose Bankundiye, Dana Boyd Barr, Vanessa Burrowes, Alejandra Bussalleu, Devan Campbell, Eduardo Canuz, Adly Castañaza, Maggie Clark, Mary Crocker, Oscar De León, Ephrem Dusabimana, Lisa Elon, Juan G Espinoza, Irma Pineda Fuentes, Ahana Ghosh, Dina Goodman, Savannah Gupton, Sarah Hamid, Steven Harvey, Mayari Hengstermann, Ian Hennessee, Phabiola Herrera, Marjorie Howard, Penelope P. Howards, Lindsay Jaacks, Katherine Kearns, Jacob Kremer, Margaret A. Laws, Pattie Lenzen, Jiawen Liao, Amy Lovvorn, Jane Mbabazi, Julia N. McPeek, Rachel Meyers, J. Jaime Miranda, Erick Mollinedo, Libny Monroy, Krishnendu Mukhopadhyay, Bernard Mutariyani, Luke P. Naeher, Abidan Nambajimana, Durairaj Natesan, Azhar Nizam, Jean de Dieu Ntivuguruzwa, Ricardo Piedrahita, Naveen Puttaswamy, Elisa Puzzolo, Ashlinn Quinn, Karthikeyan D. Rajamani, Sarah Rajkumar, Rengaraj Ramasami, Alexander Ramirez, P. Barry Ryan, Sudhakar Saidam, Zoe Sakas, Sankar Sambandam, Jeremy Sarnat, Kirk Smith, Damien Swearing, Ashley Toenjes, Lindsay Underhill, Jean D Uwizeyimana, Viviane Valdes, Amit Verma, Megan Warnock, Wenlu Ye, Bonnie Young, Ashley Younger, Libny Y. Monroy-Alarcón, Adly Castañaza Gonzalez de Durante, Claudia López-Ortega, Maria F. Gonzalez, Lakshminarayanan Sowrirajan, Shanthi P. Paramanandam, K Shanmugavadivu, V Sudharsanan, Suresh Seshadri, Adhemir E. Yupanqui-Fredes, Mario Hancco-Gomez, Ronald Apaza, Juan F. Persivale-Calle, Elizabeth Quispe, Carlos Leon-Ponce, Victor Villar-Gonzales, Rebeca Andrade-Salas, Jhon E. Herrera, Luzdelia Ramos-Mamani, Yessica Lopez, Giovanna Quiza, Yadel Hinojosa, Madeluz Gomez-Quispe, Gery Frisancho-Parada, Danielle I. Mendoza-Apaza, Luz R. Quispe-Flores, Niyitegeka F Xavier, Grace Utfimana, Elie Tuzayisenga, Valens Nkurunziza
Household air pollution might lead to fetal growth restriction during pregnancy. We aimed to investigate whether a liquefied petroleum gas (LPG) intervention to reduce personal exposures to household air pollution during pregnancy would alter fetal growth. The Household Air Pollution Intervention Network (HAPIN) trial was an open-label randomised controlled trial conducted in ten resource-limited settings across Guatemala, India, Peru, and Rwanda. Pregnant women aged 18–34 years (9–19 weeks of gestation) were randomly assigned in a 1:1 ratio to receive an LPG stove, continuous fuel delivery, and behavioural messaging or to continue usual cooking with biomass for 18 months. We conducted ultrasound assessments at baseline, 24–28 weeks of gestation (the first pregnancy visit), and 32–36 weeks of gestation (the second pregnancy visit), to measure fetal size; we monitored 24 h personal exposures to household air pollutants during these visits; and we weighed children at birth. We conducted intention-to-treat analyses to estimate differences in fetal size between the intervention and control group, and exposure–response analyses to identify associations between household air pollutants and fetal size. This trial is registered with (. Between May 7, 2018, and Feb 29, 2020, we randomly assigned 3200 pregnant women (1593 to the intervention group and 1607 to the control group). The mean gestational age was 14·5 (SD 3·0) weeks and mean maternal age was 25·6 (4·5) years. We obtained ultrasound assessments in 3147 (98·3%) women at baseline, 3052 (95·4%) women at the first pregnancy visit, and 2962 (92·6%) at the second pregnancy visit, through to Aug 25, 2020. Intervention adherence was high (the median proportion of days with biomass stove use was 0·0%, IQR 0·0–1·6) and pregnant women in the intervention group had lower mean exposures to particulate matter with a diameter less than 2·5 μm (PM; 35·0 [SD 37·2] μg/m 103·3 [97·9] μg/m) than did women in the control group. We did not find differences in averaged post-randomisation Z scores for head circumference (0·30 0·39; p=0·04), abdominal circumference (0·38 0·39; p=0·99), femur length (0·44 0·45; p=0·73), and estimated fetal weight or birthweight (–0·13 –0·12; p=0·70) between the intervention and control groups. Personal exposures to household air pollutants were not associated with fetal size. Although an LPG cooking intervention successfully reduced personal exposure to air pollution during pregnancy, it did not affect fetal size. Our findings do not support the use of unvented liquefied petroleum gas stoves as a strategy to increase fetal growth in settings were biomass fuels are used predominantly for cooking. US National Institutes of Health and Bill & Melinda Gates Foundation. For the Kinyarwanda, Spanish and Tamil translations of the abstract see Supplementary Materials section.
家庭空气污染可能会导致孕期胎儿生长受限。我们的目的是调查液化石油气(LPG)干预措施是否会改变孕期个人暴露于家庭空气污染的情况。家庭空气污染干预网络(HAPIN)试验是一项开放标签随机对照试验,在危地马拉、印度、秘鲁和卢旺达等十个资源有限的国家进行。年龄在 18-34 岁(妊娠 9-19 周)的孕妇按 1:1 的比例被随机分配到接受液化石油气炉灶、持续燃料输送和行为信息传播,或在 18 个月内继续通常的生物质烹饪方式。我们在基线期、妊娠 24-28 周(第一次妊娠访视)和妊娠 32-36 周(第二次妊娠访视)进行了超声波评估,以测量胎儿的大小;在这些访视期间,我们监测了 24 小时个人暴露于家庭空气污染物的情况;并在婴儿出生时对其进行了称重。我们进行了意向治疗分析,以估计干预组和对照组之间胎儿大小的差异,并进行了暴露反应分析,以确定家庭空气污染物与胎儿大小之间的关联。2018年5月7日至2020年2月29日期间,我们随机分配了3200名孕妇(干预组1593人,对照组1607人)。平均孕龄为14-5(SD 3-0)周,平均孕龄为25-6(4-5)岁。截至 2020 年 8 月 25 日,我们对 3147 名(98-3%)妇女进行了基线超声评估,对 3052 名(95-4%)妇女进行了首次妊娠检查,对 2962 名(92-6%)妇女进行了第二次妊娠检查。干预的坚持率很高(使用生物质炉灶的天数比例中位数为 0-0%,IQR 为 0-0-1-6),干预组孕妇接触直径小于 2-5 μm 的颗粒物(PM;35-0 [SD 37-2] μg/m 103-3 [97-9] μg/m)的平均值低于对照组孕妇。我们没有发现干预组和对照组的头围(0-30 0-39;p=0-04)、腹围(0-38 0-39;p=0-99)、股骨长(0-44 0-45;p=0-73)以及估计胎儿体重或出生体重(-0-13 -0-12;p=0-70)的随机化后平均 Z 值存在差异。个人接触家庭空气污染物与胎儿大小无关。虽然液化石油气烹饪干预措施成功地减少了孕期个人接触空气污染的机会,但并没有影响胎儿的大小。我们的研究结果不支持在主要使用生物质燃料做饭的环境中使用无排气装置的液化石油气炉灶作为增加胎儿发育的策略。美国国立卫生研究院和比尔及梅琳达-盖茨基金会。摘要的基尼亚卢旺达语、西班牙语和泰米尔语译文见 "补充材料 "部分。
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Howards, Lindsay Jaacks, Katherine Kearns, Jacob Kremer, Margaret A. Laws, Pattie Lenzen, Jiawen Liao, Amy Lovvorn, Jane Mbabazi, Julia N. McPeek, Rachel Meyers, J. Jaime Miranda, Erick Mollinedo, Libny Monroy, Krishnendu Mukhopadhyay, Bernard Mutariyani, Luke P. Naeher, Abidan Nambajimana, Durairaj Natesan, Azhar Nizam, Jean de Dieu Ntivuguruzwa, Ricardo Piedrahita, Naveen Puttaswamy, Elisa Puzzolo, Ashlinn Quinn, Karthikeyan D. Rajamani, Sarah Rajkumar, Rengaraj Ramasami, Alexander Ramirez, P. Barry Ryan, Sudhakar Saidam, Zoe Sakas, Sankar Sambandam, Jeremy Sarnat, Kirk Smith, Damien Swearing, Ashley Toenjes, Lindsay Underhill, Jean D Uwizeyimana, Viviane Valdes, Amit Verma, Megan Warnock, Wenlu Ye, Bonnie Young, Ashley Younger, Libny Y. Monroy-Alarcón, Adly Castañaza Gonzalez de Durante, Claudia López-Ortega, Maria F. Gonzalez, Lakshminarayanan Sowrirajan, Shanthi P. Paramanandam, K Shanmugavadivu, V Sudharsanan, Suresh Seshadri, Adhemir E. Yupanqui-Fredes, Mario Hancco-Gomez, Ronald Apaza, Juan F. Persivale-Calle, Elizabeth Quispe, Carlos Leon-Ponce, Victor Villar-Gonzales, Rebeca Andrade-Salas, Jhon E. Herrera, Luzdelia Ramos-Mamani, Yessica Lopez, Giovanna Quiza, Yadel Hinojosa, Madeluz Gomez-Quispe, Gery Frisancho-Parada, Danielle I. Mendoza-Apaza, Luz R. Quispe-Flores, Niyitegeka F Xavier, Grace Utfimana, Elie Tuzayisenga, Valens Nkurunziza","doi":"10.1016/s2214-109x(24)00033-0","DOIUrl":"https://doi.org/10.1016/s2214-109x(24)00033-0","url":null,"abstract":"Household air pollution might lead to fetal growth restriction during pregnancy. We aimed to investigate whether a liquefied petroleum gas (LPG) intervention to reduce personal exposures to household air pollution during pregnancy would alter fetal growth. The Household Air Pollution Intervention Network (HAPIN) trial was an open-label randomised controlled trial conducted in ten resource-limited settings across Guatemala, India, Peru, and Rwanda. Pregnant women aged 18–34 years (9–19 weeks of gestation) were randomly assigned in a 1:1 ratio to receive an LPG stove, continuous fuel delivery, and behavioural messaging or to continue usual cooking with biomass for 18 months. We conducted ultrasound assessments at baseline, 24–28 weeks of gestation (the first pregnancy visit), and 32–36 weeks of gestation (the second pregnancy visit), to measure fetal size; we monitored 24 h personal exposures to household air pollutants during these visits; and we weighed children at birth. We conducted intention-to-treat analyses to estimate differences in fetal size between the intervention and control group, and exposure–response analyses to identify associations between household air pollutants and fetal size. This trial is registered with (. Between May 7, 2018, and Feb 29, 2020, we randomly assigned 3200 pregnant women (1593 to the intervention group and 1607 to the control group). The mean gestational age was 14·5 (SD 3·0) weeks and mean maternal age was 25·6 (4·5) years. We obtained ultrasound assessments in 3147 (98·3%) women at baseline, 3052 (95·4%) women at the first pregnancy visit, and 2962 (92·6%) at the second pregnancy visit, through to Aug 25, 2020. Intervention adherence was high (the median proportion of days with biomass stove use was 0·0%, IQR 0·0–1·6) and pregnant women in the intervention group had lower mean exposures to particulate matter with a diameter less than 2·5 μm (PM; 35·0 [SD 37·2] μg/m 103·3 [97·9] μg/m) than did women in the control group. We did not find differences in averaged post-randomisation Z scores for head circumference (0·30 0·39; p=0·04), abdominal circumference (0·38 0·39; p=0·99), femur length (0·44 0·45; p=0·73), and estimated fetal weight or birthweight (–0·13 –0·12; p=0·70) between the intervention and control groups. Personal exposures to household air pollutants were not associated with fetal size. Although an LPG cooking intervention successfully reduced personal exposure to air pollution during pregnancy, it did not affect fetal size. Our findings do not support the use of unvented liquefied petroleum gas stoves as a strategy to increase fetal growth in settings were biomass fuels are used predominantly for cooking. US National Institutes of Health and Bill & Melinda Gates Foundation. 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引用次数: 0
Thinking beyond diagnostic accuracy to evaluate tuberculosis screening tests 评估肺结核筛查试验的思维超越诊断准确性
IF 34.3 1区 医学 Q1 Medicine Pub Date : 2024-04-04 DOI: 10.1016/s2214-109x(24)00061-5
Emily L-H MacLean, H Manisha Yapa
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引用次数: 0
Blood RNA biomarkers for tuberculosis screening in people living with HIV before antiretroviral therapy initiation: a diagnostic accuracy study 在开始接受抗逆转录病毒疗法前筛查艾滋病毒感染者结核病的血液 RNA 生物标志物:诊断准确性研究
IF 34.3 1区 医学 Q1 Medicine Pub Date : 2024-04-04 DOI: 10.1016/s2214-109x(24)00029-9
Tiffeney Mann MSc, Rishi K Gupta PhD, Byron W P Reeve PhD, Gcobisa Ndlangalavu PhD, Aneesh Chandran PhD, Amirtha P Krishna BSc, Claire J Calderwood MRCP, Happy Tshivhula PhD, Zaida Palmer MSc, Selisha Naidoo MSc, Desiree L Mbu MSc, Grant Theron PhD, Prof Mahdad Noursadeghi PhD
Undiagnosed tuberculosis remains a major threat for people living with HIV. Multiple blood transcriptomic biomarkers have shown promise for tuberculosis diagnosis. We sought to evaluate their diagnostic accuracy and clinical utility for systematic pre-antiretroviral therapy (ART) tuberculosis screening. We enrolled consecutive adults (age ≥18 years) referred to start ART at a community health centre in Cape Town, South Africa, irrespective of symptoms. Sputa were obtained (using induction if required) for two liquid cultures. Whole-blood RNA samples underwent transcriptional profiling using a custom Nanostring gene panel. We measured the diagnostic accuracy of seven candidate RNA signatures (one single gene biomarker [BATF2] and six multigene biomarkers) for the reference standard of culture status, using area under the receiver-operating characteristic curve (AUROC) analysis, and sensitivity and specificity at prespecified thresholds (two standard scores above the mean of healthy controls; Z2). Clinical utility was assessed by calculating net benefit in decision curve analysis. We compared performance with C-reactive protein (CRP; threshold ≥5 mg/L), WHO four-symptom screen (W4SS), and the WHO target product profile for tuberculosis triage tests. A total of 707 people living with HIV (407 [58%] female and 300 [42%] male) were included, with median CD4 count 306 cells per mm (IQR 184–486). Of 676 participants with available sputum culture results, 89 (13%) had culture-confirmed tuberculosis. The seven RNA signatures were moderately to highly correlated (Spearman rank coefficients 0·42–0·93) and discriminated tuberculosis culture positivity with similar AUROCs (0·73–0·80), but none statistically better than CRP (AUROC 0·78, 95% CI 0·72–0·83). Diagnostic accuracy was similar across CD4 count strata, but lower among participants with negative W4SS (AUROCs 0·56–0·65) compared with positive (AUROCs 0·75–0·84). The RNA biomarker with the highest AUROC point estimate was a four-gene signature (Suliman4; AUROC 0·80, 95% CI 0·75–0·86), with sensitivity 83% (95% CI 74–90) and specificity 59% (55–63) at the Z2 threshold. In decision curve analysis, Suliman4 and CRP had similar clinical utility to guide confirmatory tuberculosis testing, but both had higher net benefit than W4SS. In exploratory analyses, an approach combining CRP (≥5 mg/L) and Suliman4 (≥Z2) had sensitivity of 80% (70–87), specificity of 70% (66–74), and higher net benefit than either biomarker alone. RNA biomarkers showed better clinical utility to guide confirmatory tuberculosis testing for people living with HIV before ART initiation than symptom-based screening, but their performance did not exceed that of CRP and fell short of WHO recommended targets. Interferon-independent approaches might be required to improve accuracy of host-response biomarkers to support tuberculosis screening before ART initiation. South African Medical Research Council, European and Developing Countries Clinical
未确诊的结核病仍然是艾滋病毒感染者面临的一大威胁。多种血液转录组生物标志物已显示出诊断结核病的前景。我们试图评估它们在系统性抗逆转录病毒疗法(ART)前结核病筛查中的诊断准确性和临床实用性。我们在南非开普敦的一家社区医疗中心连续招募了转诊开始接受抗逆转录病毒疗法的成年人(年龄≥18 岁),无论其是否有症状。我们采集了痰液(必要时采用诱导法),进行了两次液体培养。全血 RNA 样本使用定制的 Nanostring 基因面板进行转录分析。我们使用接收者工作特征曲线下面积(AUROC)分析以及预设阈值(比健康对照组平均值高两个标准分;Z2)下的灵敏度和特异性,测量了七个候选 RNA 标志(一个单基因生物标志物 [BATF2] 和六个多基因生物标志物)对培养状态参考标准的诊断准确性。临床实用性通过计算决策曲线分析中的净获益进行评估。我们比较了 C 反应蛋白(CRP;阈值≥5 mg/L)、世界卫生组织四症状筛查(W4SS)和世界卫生组织结核病分诊测试目标产品描述的性能。共纳入了 707 名艾滋病毒感染者(其中女性 407 人[58%],男性 300 人[42%]),CD4 细胞计数中位数为 306 个/毫米(IQR 184-486)。在 676 名有痰培养结果的参与者中,89 人(13%)经培养证实患有结核病。七种 RNA 特征具有中度到高度相关性(斯皮尔曼秩系数 0-42-0-93),对结核菌培养阳性的判别具有相似的 AUROC(0-73-0-80),但在统计学上都不优于 CRP(AUROC 0-78,95% CI 0-72-0-83)。各 CD4 细胞数层的诊断准确性相似,但 W4SS 阴性参与者的诊断准确性(AUROCs 0-56-0-65)低于 W4SS 阳性参与者(AUROCs 0-75-0-84)。AUROC点估计值最高的 RNA 生物标志物是四基因特征(Suliman4;AUROC 0-80,95% CI 0-75-0-86),在 Z2 临界值时灵敏度为 83%(95% CI 74-90),特异性为 59%(55-63)。在决策曲线分析中,Suliman4 和 CRP 在指导肺结核确诊检测方面具有相似的临床效用,但两者的净效益均高于 W4SS。在探索性分析中,结合 CRP(≥5 mg/L)和 Suliman4(≥Z2)的方法的灵敏度为 80%(70-87),特异性为 70%(66-74),净效益高于单独使用其中一种生物标记物的方法。与基于症状的筛查相比,RNA 生物标志物在指导艾滋病病毒感染者开始抗逆转录病毒疗法前的结核病确诊检测方面显示出更好的临床实用性,但其性能并未超过 CRP,也未达到世界卫生组织推荐的目标。可能需要采用不依赖干扰素的方法来提高宿主反应生物标志物的准确性,以支持抗逆转录病毒疗法启动前的结核病筛查。南非医学研究理事会、欧洲与发展中国家临床试验合作组织 2、美国国立卫生研究院国家过敏与传染病研究所、惠康信托基金会、国家健康与护理研究所、伦敦皇家内科医学院。
{"title":"Blood RNA biomarkers for tuberculosis screening in people living with HIV before antiretroviral therapy initiation: a diagnostic accuracy study","authors":"Tiffeney Mann MSc, Rishi K Gupta PhD, Byron W P Reeve PhD, Gcobisa Ndlangalavu PhD, Aneesh Chandran PhD, Amirtha P Krishna BSc, Claire J Calderwood MRCP, Happy Tshivhula PhD, Zaida Palmer MSc, Selisha Naidoo MSc, Desiree L Mbu MSc, Grant Theron PhD, Prof Mahdad Noursadeghi PhD","doi":"10.1016/s2214-109x(24)00029-9","DOIUrl":"https://doi.org/10.1016/s2214-109x(24)00029-9","url":null,"abstract":"Undiagnosed tuberculosis remains a major threat for people living with HIV. Multiple blood transcriptomic biomarkers have shown promise for tuberculosis diagnosis. We sought to evaluate their diagnostic accuracy and clinical utility for systematic pre-antiretroviral therapy (ART) tuberculosis screening. We enrolled consecutive adults (age ≥18 years) referred to start ART at a community health centre in Cape Town, South Africa, irrespective of symptoms. Sputa were obtained (using induction if required) for two liquid cultures. Whole-blood RNA samples underwent transcriptional profiling using a custom Nanostring gene panel. We measured the diagnostic accuracy of seven candidate RNA signatures (one single gene biomarker [BATF2] and six multigene biomarkers) for the reference standard of culture status, using area under the receiver-operating characteristic curve (AUROC) analysis, and sensitivity and specificity at prespecified thresholds (two standard scores above the mean of healthy controls; Z2). Clinical utility was assessed by calculating net benefit in decision curve analysis. We compared performance with C-reactive protein (CRP; threshold ≥5 mg/L), WHO four-symptom screen (W4SS), and the WHO target product profile for tuberculosis triage tests. A total of 707 people living with HIV (407 [58%] female and 300 [42%] male) were included, with median CD4 count 306 cells per mm (IQR 184–486). Of 676 participants with available sputum culture results, 89 (13%) had culture-confirmed tuberculosis. The seven RNA signatures were moderately to highly correlated (Spearman rank coefficients 0·42–0·93) and discriminated tuberculosis culture positivity with similar AUROCs (0·73–0·80), but none statistically better than CRP (AUROC 0·78, 95% CI 0·72–0·83). Diagnostic accuracy was similar across CD4 count strata, but lower among participants with negative W4SS (AUROCs 0·56–0·65) compared with positive (AUROCs 0·75–0·84). The RNA biomarker with the highest AUROC point estimate was a four-gene signature (Suliman4; AUROC 0·80, 95% CI 0·75–0·86), with sensitivity 83% (95% CI 74–90) and specificity 59% (55–63) at the Z2 threshold. In decision curve analysis, Suliman4 and CRP had similar clinical utility to guide confirmatory tuberculosis testing, but both had higher net benefit than W4SS. In exploratory analyses, an approach combining CRP (≥5 mg/L) and Suliman4 (≥Z2) had sensitivity of 80% (70–87), specificity of 70% (66–74), and higher net benefit than either biomarker alone. RNA biomarkers showed better clinical utility to guide confirmatory tuberculosis testing for people living with HIV before ART initiation than symptom-based screening, but their performance did not exceed that of CRP and fell short of WHO recommended targets. Interferon-independent approaches might be required to improve accuracy of host-response biomarkers to support tuberculosis screening before ART initiation. South African Medical Research Council, European and Developing Countries Clinical","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":null,"pages":null},"PeriodicalIF":34.3,"publicationDate":"2024-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140553515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Point-of-care C-reactive protein and Xpert MTB/RIF Ultra for tuberculosis screening and diagnosis in unselected antiretroviral therapy initiators: a prospective, cross-sectional, diagnostic accuracy study 用于未经选择的抗逆转录病毒疗法启动者结核病筛查和诊断的床旁 C 反应蛋白和 Xpert MTB/RIF Ultra:一项前瞻性横断面诊断准确性研究
IF 34.3 1区 医学 Q1 Medicine Pub Date : 2024-04-04 DOI: 10.1016/s2214-109x(24)00052-4
Byron W P Reeve PhD, Gcobisa Ndlangalavu PhD, Hridesh Mishra PhD, Zaida Palmer MSc, Happy Tshivhula PhD, Loren Rockman BSc (Hons), Selisha Naidoo MSc, Desiree L Mbu MSc, Charissa C Naidoo PhD, Brigitta Derendinger PhD, Prof Gerhard Walzl MD PhD, Stephanus T Malherbe MD PhD, Prof Paul D van Helden PhD, Fred C Semitala MD, Christina Yoon MD, Rishi K Gupta MRCP PhD, Prof Mahdad Noursadeghi FRCP PhD, Prof Robin M Warren PhD, Prof Grant Theron PhD
Tuberculosis, a major cause of death in people living with HIV, remains challenging to diagnose. Diagnostic accuracy data are scarce for promising triage and confirmatory tests such as C-reactive protein (CRP), sputum and urine Xpert MTB/RIF Ultra (Xpert Ultra), and urine Determine TB LAM Ag (a lateral flow lipoarabinomannan [LF-LAM] test), without symptom selection. We evaluated novel triage and confirmatory tests in ambulatory people with HIV initiating antiretroviral therapy (ART). 897 ART-initiators were recruited irrespective of symptoms and sputum induction offered. For triage (n=800), we evaluated point-of-care blood-based CRP testing, compared with the WHO-recommended four-symptom screen (W4SS). For sputum-based confirmatory testing (n=787), we evaluated Xpert Ultra versus Xpert MTB/RIF (Xpert). For urine-based confirmatory testing (n=732), we evaluated Xpert Ultra and LF-LAM. We used a sputum culture reference standard. 463 (52%) of 897 participants were female. The areas under the receiver operator characteristic curves for CRP was 0·78 (95% CI 0·73–0·83) and for number of W4SS symptoms was 0·70 (0·64–0·75). CRP (≥10 mg/L) had similar sensitivity to W4SS (77% [95% CI 68–85; 80/104] 77% [68–85; 80/104]; p>0·99] but higher specificity (64% [61–68; 445/696] 48% [45–52; 334/696]; p<0·0001]; reducing unnecessary confirmatory testing by 138 (95% CI 117–160) per 1000 people and number-needed-to-test from 6·91 (95% CI 6·25–7·81) to 4·87 (4·41–5·51). Sputum samples with Xpert Ultra, which required induction in 49 (31%) of 158 of people (95% CI 24–39), had higher sensitivity than Xpert (71% [95% CI 61–80; 74/104] 56% [46–66; 58/104]; p<0·0001). Of the people with one or more confirmatory sputum or urine test results that were positive, the proportion detected by Xpert Ultra increased from 45% (26–64) to 66% (46–82) with induction. Programmatically done haemoglobin, triage test combinations, and urine tests showed comparatively worse results. CRP is a more specific triage test than W4SS in those initiating ART. Sputum induction improves diagnostic yield. Sputum samples with Xpert Ultra is a more accurate confirmatory test than with Xpert. South African Medical Research Council, EDCTP2, US National Institutes of Health–National Institute of Allergy and Infectious Diseases.
结核病是导致艾滋病病毒感染者死亡的一个主要原因,但其诊断仍然具有挑战性。C反应蛋白(CRP)、痰液和尿液 Xpert MTB/RIF Ultra(Xpert Ultra)以及尿液 Determine TB LAM Ag(一种侧流脂联菌素[LF-LAM]检测)等有前途的分诊和确诊检测方法,在没有症状选择的情况下,诊断准确率数据很少。我们对开始接受抗逆转录病毒疗法(ART)的门诊艾滋病病毒感染者进行了新型分诊和确证检验的评估。我们招募了 897 名开始接受抗逆转录病毒疗法的患者,无论其症状如何,是否提供痰液诱导。对于分流(800 人),我们评估了基于血液的床旁 CRP 检测,并与世界卫生组织推荐的四症状筛查(W4SS)进行了比较。对于基于痰液的确证检测(787 人),我们评估了 Xpert Ultra 与 Xpert MTB/RIF (Xpert)。对于尿液确证检验(732 人),我们评估了 Xpert Ultra 和 LF-LAM。我们采用了痰培养参考标准。897 名参与者中有 463 人(52%)为女性。CRP和W4SS症状数量的接收者操作特征曲线下面积分别为0-78(95% CI 0-73-0-83)和0-70(0-64-0-75)。CRP(≥10 mg/L)的敏感性与 W4SS 相似(77% [95% CI 68-85; 80/104] 77% [68-85; 80/104]; p>0-99),但特异性更高(64% [61-68; 445/696] 48% [45-52; 334/696];p<0-0001];每 1000 人中不必要的确证检测减少 138 例(95% CI 117-160 例),检测所需人数从 6-91 例(95% CI 6-25-7-81 例)减少到 4-87 例(4-41-51-51 例)。158 人中有 49 人(31%)(95% CI 24-39)的痰标本需要 Xpert Ultra 诱导检测,其灵敏度高于 Xpert(71% [95% CI 61-80; 74/104] 56% [46-66; 58/104];P<0-0001)。在有一次或多次痰液或尿液确证检测结果呈阳性的人群中,经 Xpert Ultra 检测出的比例从 45% (26-64) 增加到 66% (46-82)。按程序进行的血红蛋白、分诊检验组合和尿液检验的结果相对较差。在开始接受抗逆转录病毒疗法的患者中,CRP 是比 W4SS 更特异的分流检测方法。痰液诱导可提高诊断率。使用 Xpert Ultra 对痰样本进行确诊比使用 Xpert 进行确诊更为准确。南非医学研究委员会、EDCTP2、美国国立卫生研究院-国立过敏与传染病研究所。
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Lancet Global Health
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