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The apparent burden of unexplained sudden infant deaths in Lusaka, Zambia: Findings from analysis of verbal autopsies 赞比亚卢萨卡不明原因婴儿猝死的明显负担:言语尸检分析结果
Pub Date : 2023-02-15 DOI: 10.12688/gatesopenres.14303.1
Godwin K. Osei-Poku, L. Mwananyanda, Patricia A Elliott, W. MacLeod, S. W. Somwe, R. Pieciak, C. Gill
Background: The contribution of sudden unexpected infant death (SUID) has received little attention in global health. The objective of this study was to estimate the burden of SUID in Lusaka, Zambia. Methods: Verbal autopsies were conducted on infants who died in Lusaka, between 2017 and 2020.  From these, we performed a qualitative analysis of the free text narratives of the final series of events leading to each infant’s death and classified these as symptomatic deaths or SUID. Any narrative that described an infant who was otherwise healthy with no antecedent illness prior to death and found dead in bed after a sleep episode was classified as SUID. We used logistic regression to test for statistical differences between asymptomatic deaths and SUIDs on key infant, maternal and other risk factors of SUIDs. Results: Eight hundred and nine verbal autopsies were conducted with families of decedent infants younger than six months of age. A total of 92.6% (749/809) had presented with symptoms prior to death, whereas 7.4% (60/809) died without preceding symptoms or obvious cause of death. Of these, 16/60 were compatible with accidental suffocation deaths, and 54/60 appeared to be sudden infant death syndrome.  SUID deaths were concentrated in infants younger than two months of age with peak age of one to two months. Age at death was the only significant factor in multivariate analysis. Infants aged between one and two months had 2.84 increased odds of suspected SUIDs compared to infants in the first month of life (aOR = 2.84, 95% CI: 1.31, 6.16). Conclusions: Our findings suggest SUID could be accounting for a significant proportion of infant deaths in Zambia, but this cause of infant mortality is going unrecognized. Public health interventions in Zambia, and Africa more broadly, are likely overlooking SUIDs as an important cause of infant mortality.
背景:婴儿猝死(SUID)的影响在全球卫生领域很少受到关注。本研究的目的是估计赞比亚卢萨卡SUID的负担。方法:对2017年至2020年间在卢萨卡死亡的婴儿进行口头尸检。根据这些尸检,我们对导致每个婴儿死亡的最后一系列事件的自由文本叙述进行了定性分析,并将其归类为症状性死亡或SUID。任何描述婴儿在死亡前健康无前期疾病,并在睡眠后被发现死于床上的叙述都被归类为SUID。我们使用逻辑回归来检验无症状死亡和SUID在婴儿、母亲和其他SUID危险因素方面的统计差异。结果:对六个月以下婴儿的家属进行了890次口头尸检。共有92.6%(749/809)的患者在死亡前出现症状,而7.4%(60/809)的患者死亡时没有出现症状或明显的死因。其中,16/60与意外窒息死亡相符,54/60似乎是婴儿猝死综合征。SUID死亡集中在两个月以下的婴儿,高峰年龄为一到两个月。死亡年龄是多变量分析中唯一的显著因素。与出生第一个月的婴儿相比,1至2个月大的婴儿疑似SUID的几率增加了2.84(aOR=2.84,95%CI:1.31,6.16)。结论:我们的研究结果表明,SUID可能在赞比亚婴儿死亡中占很大比例,但婴儿死亡的这一原因尚不清楚。赞比亚和更广泛的非洲的公共卫生干预措施可能忽视了SUID作为婴儿死亡率的重要原因。
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引用次数: 2
The economic costs of malaria in pregnancy: evidence from four sub-Saharan countries 妊娠期疟疾的经济代价:来自四个撒哈拉以南国家的证据
Pub Date : 2023-02-15 DOI: 10.12688/gatesopenres.14375.1
Laia Cirera, Charfudin Sacoor, Martin Meremikwu, Louise Ranaivo, Manu F. Manun’Ebo, Dachi Arikpo, Osvaledo Matavele, Victor Rafaralahy, Didier Ndombe, Clara Pons Duran, Maximo Ramirez, Francesco Ramponi, Raquel González, Christina Maly, Elaine Roman, Elisa Sicuri, Franco Pagnoni, Clara Menéndez
Background Malaria in pregnancy is a major public health problem in sub-Saharan Africa (SSA), which imposes a significant economic burden. We provide evidence on the costs of malaria care in pregnancy to households and the health system in four high-burden countries in SSA. Methods Household and health system economic costs associated with malaria control in pregnancy were estimated in selected areas of the Democratic Republic of Congo (DRC), Madagascar (MDG), Mozambique (MOZ) and Nigeria (NGA). An exit survey was administered to 2,031 pregnant women when leaving the antenatal care (ANC) clinic from October 2020 to June 2021. Women reported the direct and indirect costs associated to malaria prevention and treatment in pregnancy. To estimate health system costs, we interviewed health workers from 133 randomly selected health facilities. Costs were estimated using an ingredients-based approach. Results Average household costs of malaria prevention per pregnancy were USD6.33 in DRC, USD10.06 in MDG, USD15.03 in MOZ and USD13.33 in NGA. Household costs of treating an episode of uncomplicated/complicated malaria were USD22.78/USD46 in DRC, USD16.65/USD35.65 in MDG, USD30.54/USD61.25 in MOZ and USD18.92/USD44.71 in NGA, respectively. Average health system costs of malaria prevention per pregnancy were USD10.74 in DRC, USD16.95 in MDG, USD11.17 in MOZ and USD15.64 in NGA. Health system costs associated with treating an episode of uncomplicated/complicated malaria were USD4.69/USD101.41 in DRC, USD3.61/USD63.33 in MDG, USD4.68/USD83.70 in MOZ and USD4.09/USD92.64 in NGA. These estimates resulted in societal costs of malaria prevention and treatment per pregnancy of USD31.72 in DRC, USD29.77 in MDG, USD31.98 in MOZ and USD46.16 in NGA. Conclusions Malaria in pregnancy imposes a high economic burden on households and the health system. Findings emphasize the importance of investing in effective strategies that improve access to malaria control and reduce the burden of the infection in pregnancy.
妊娠期疟疾是撒哈拉以南非洲(SSA)的一个主要公共卫生问题,造成了严重的经济负担。我们提供了在非洲南部地区四个高负担国家对家庭和卫生系统的孕期疟疾护理费用的证据。方法对刚果民主共和国(DRC)、马达加斯加(MDG)、莫桑比克(MOZ)和尼日利亚(NGA)选定地区与妊娠期疟疾控制相关的家庭和卫生系统经济成本进行估算。2020年10月至2021年6月,对2031名离开产前护理(ANC)诊所的孕妇进行了退出调查。妇女报告了与怀孕期间预防和治疗疟疾有关的直接和间接费用。为了估计卫生系统成本,我们采访了来自133个随机选择的卫生机构的卫生工作者。使用基于成分的方法估算成本。结果DRC、MDG、MOZ和NGA的家庭平均妊娠期疟疾预防费用分别为6.33美元、10.06美元、15.03美元和13.33美元。治疗一次无并发症/复杂疟疾的家庭费用在刚果民主共和国为22.78美元/ 46美元,在千年发展目标为16.65美元/ 35.65美元,在莫桑比克为30.54美元/ 61.25美元,在加纳为18.92美元/ 44.71美元。刚果民主共和国每次怀孕预防疟疾的平均卫生系统成本为10.74美元,千年发展目标为16.95美元,莫桑比克为11.17美元,加纳为15.64美元。在刚果民主共和国,治疗一次非复杂/复杂疟疾的相关卫生系统成本为4.69美元/ 101.41美元,在千年发展目标中为3.61美元/ 63.33美元,在莫桑比克为4.68美元/ 83.70美元,在加纳为4.09美元/ 92.64美元。根据这些估计,刚果民主共和国预防和治疗每次妊娠疟疾的社会成本为31.72美元,千年发展目标为29.77美元,莫桑比克为31.98美元,加纳为46.16美元。结论妊娠期疟疾给家庭和卫生系统带来了沉重的经济负担。调查结果强调了投资于有效战略的重要性,这些战略可改善获得疟疾控制的机会并减轻妊娠期感染的负担。
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引用次数: 1
Uptake of same-day initiation of HIV treatment among adult men and women in Malawi, South Africa, and Zambia: the SPRINT retrospective cohort study 马拉维、南非和赞比亚成年男性和女性当天开始接受艾滋病毒治疗:SPRINT回顾性队列研究
Pub Date : 2023-02-14 DOI: 10.12688/gatesopenres.14424.1
Amy Huber, Kamban Hirasen, Alana T. Brennan, Bevis Phiri, Timothy Tcherini, Lloyd Mulenga, Prudence Haimbe, Hilda Shakwelele, Rose Nyirenda, Bilaal Wilson Matola, Andrews Gunda, Sydney Rosen
Background: Since 2017 global guidelines have recommended “same-day initiation” (SDI) of antiretroviral treatment (ART) for patients considered ready for treatment on the day of HIV diagnosis. Many countries have incorporated a SDI option into national guidelines, but SDI uptake is not well documented. We estimated average time to ART initiation at 12 public healthcare facilities in Malawi, five in South Africa, and 12 in Zambia. Methods: We sequentially enrolled patients eligible to start ART between January 2018 and June 2019 and reviewed their medical records from the point of HIV diagnosis or first HIV-related interaction with the clinic to the earlier date of treatment initiation or 6 months. We estimated the proportion of patients initiating ART on the same day or within 7, 14, 30, or 180 days of baseline. Results: We enrolled 826 patients in Malawi, 534 in South Africa, and 1,984 in Zambia. Overall, 88% of patients in Malawi, 57% in South Africa, and 91% in Zambia were offered and accepted SDI. In Malawi, most who did not receive SDI had not initiated ART ≤6 months. In South Africa, an additional 13% initiated ≤1 week, but 21% had no record of initiation ≤6 months. Among those who did initiate within 6 months in Zambia, most started ≤1 week. There were no major differences by sex. WHO Stage III/IV and tuberculosis symptoms were associated with delays in ART initiation. Conclusions: As of 2020, SDI of ART was widespread, if not nearly universal, in Malawi and Zambia but considerably less common in South Africa. Limitations of the study include pre-COVID-19 data that do not reflect pandemic adaptations and potentially missing data for Zambia. South Africa may be able to increase overall ART coverage by reducing numbers of patients who do not initiate ≤6 months. Registration: Clinicaltrials.gov (NCT04468399; NCT04170374; NCT04470011).
背景:自2017年以来,全球指南建议对在艾滋病毒诊断当天被认为准备接受治疗的患者“当日开始”抗逆转录病毒治疗(ART)。许多国家已将SDI选项纳入国家指南,但SDI的使用情况没有很好的记录。我们估计了马拉维12个、南非5个和赞比亚12个公共医疗机构开始抗逆转录病毒治疗的平均时间。方法:我们在2018年1月至2019年6月期间依次招募符合条件的患者开始抗逆转录病毒治疗,并回顾了他们的医疗记录,从HIV诊断或首次与临床HIV相关的相互作用到开始治疗的较早日期或6个月。我们估计了在基线的同一天或在7天、14天、30天或180天内开始抗逆转录病毒治疗的患者比例。结果:我们在马拉维招募了826名患者,在南非招募了534名患者,在赞比亚招募了1984名患者。总体而言,马拉维88%的患者、南非57%的患者和赞比亚91%的患者接受了SDI治疗。在马拉维,大多数未接受SDI的患者≤6个月未开始抗逆转录病毒治疗。在南非,另外13%的人开始≤1周,但21%的人没有开始≤6个月的记录。在赞比亚6个月内开始治疗的患者中,大多数开始≤1周。性别差异不大。世卫组织III/IV期和结核病症状与延迟开始抗逆转录病毒治疗有关。结论:截至2020年,抗逆转录病毒药物的SDI在马拉维和赞比亚很普遍,如果不是几乎普遍的话,但在南非却不那么普遍。该研究的局限性包括covid -19前的数据不能反映大流行的适应情况,以及赞比亚可能缺少的数据。南非可以通过减少≤6个月未开始接受抗逆转录病毒治疗的患者人数来增加总的抗逆转录病毒治疗覆盖率。注册:Clinicaltrials.gov (NCT04468399;NCT04170374;NCT04470011)。
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引用次数: 1
Systematic review of diagnostic and prognostic host blood transcriptomic signatures of tuberculosis disease in people living with HIV 对艾滋病毒感染者结核病诊断和预后宿主血液转录组特征的系统评价
Pub Date : 2023-02-03 DOI: 10.12688/gatesopenres.14327.1
Simon C Mendelsohn, Savannah Verhage, Humphrey Mulenga, Thomas J Scriba, Mark Hatherill
Background HIV-associated tuberculosis (TB) has high mortality; however, current triage and prognostic tools offer poor sensitivity and specificity, respectively. We conducted a systematic review of diagnostic and prognostic host-blood transcriptomic signatures of TB in people living with HIV (PLHIV). Methods We systematically searched online databases for studies published in English between 1990-2020. Eligible studies included PLHIV of any age in test or validation cohorts, and used microbiological or composite reference standards for TB diagnosis. Inclusion was not restricted by setting or participant age. Study selection, quality appraisal using the QUADAS-2 tool, and data extraction were conducted independently by two reviewers. Thereafter, narrative synthesis of included studies, and comparison of signatures performance, was performed. Results We screened 1,580 records and included 12 studies evaluating 31 host-blood transcriptomic signatures in 10 test or validation cohorts of PLHIV that differentiated individuals with TB from those with HIV alone, latent Mycobacterium tuberculosis infection, or other diseases (OD). Two (2/10; 20%) cohorts were prospective (29 TB cases; 51 OD) and 8 (80%) case-control (353 TB cases; 606 controls) design. All cohorts (10/10) were recruited in Sub-Saharan Africa and 9/10 (90%) had a high risk of bias. Ten signatures (10/31; 32%) met minimum WHO Target Product Profile (TPP) criteria for TB triage tests. Only one study (1/12; 8%) evaluated prognostic performance of a transcriptomic signature for progression to TB in PLHIV, which did not meet the minimum WHO prognostic TPP. Conclusions Generalisability of reported findings is limited by few studies enrolling PLHIV, limited geographical diversity, and predominantly case-control design, which also introduces spectrum bias. New prospective cohort studies are needed that include PLHIV and are conducted in diverse settings. Further research exploring the effect of HIV clinical, virological, and immunological factors on diagnostic performance is necessary for development and implementation of TB transcriptomic signatures in PLHIV.
hiv相关结核病(TB)死亡率高;然而,目前的分诊和预后工具分别提供较差的敏感性和特异性。我们对HIV感染者(PLHIV)中结核病的诊断和预后宿主血转录组特征进行了系统回顾。方法系统地检索在线数据库中1990-2020年间发表的英文研究。符合条件的研究包括测试或验证队列中任何年龄的PLHIV,并使用微生物或复合参考标准进行结核病诊断。纳入不受环境或参与者年龄的限制。研究选择、使用QUADAS-2工具进行质量评价和数据提取由两位审稿人独立进行。此后,对纳入的研究进行叙事综合,并对签名表现进行比较。结果:我们筛选了1580条记录,包括12项研究,评估了10个PLHIV测试或验证队列中的31个宿主血转录组特征,这些研究将结核病患者与单独感染HIV、潜伏结核分枝杆菌感染或其他疾病(OD)的患者区分开来。两个(2/10;20%)队列为前瞻性队列(29例结核病例;51例OD)和8例(80%)病例对照(353例TB);606控制)设计。所有队列(10/10)在撒哈拉以南非洲招募,9/10(90%)具有高偏倚风险。十个签名(10/31;32%)符合世卫组织结核病分诊检测的最低目标产品概况标准。只有一项研究(1/12;8%)评估了PLHIV进展为结核病的转录组特征的预后表现,未达到WHO预后TPP的最低标准。结论:纳入PLHIV的研究较少,地理多样性有限,主要是病例对照设计,这些都限制了报告结果的普遍性,这也引入了谱偏倚。需要新的前瞻性队列研究,包括在不同环境中进行的PLHIV。进一步研究HIV临床、病毒学和免疫学因素对诊断性能的影响,对于开发和实施PLHIV的TB转录组特征是必要的。
{"title":"Systematic review of diagnostic and prognostic host blood transcriptomic signatures of tuberculosis disease in people living with HIV","authors":"Simon C Mendelsohn, Savannah Verhage, Humphrey Mulenga, Thomas J Scriba, Mark Hatherill","doi":"10.12688/gatesopenres.14327.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.14327.1","url":null,"abstract":"<ns4:p><ns4:bold>Background</ns4:bold></ns4:p><ns4:p> HIV-associated tuberculosis (TB) has high mortality; however, current triage and prognostic tools offer poor sensitivity and specificity, respectively. We conducted a systematic review of diagnostic and prognostic host-blood transcriptomic signatures of TB in people living with HIV (PLHIV).</ns4:p><ns4:p> </ns4:p><ns4:p> <ns4:bold>Methods</ns4:bold></ns4:p><ns4:p> We systematically searched online<ns4:italic> </ns4:italic>databases for studies published in English between 1990-2020. Eligible studies included PLHIV of any age in test or validation cohorts, and used microbiological or composite reference standards for TB diagnosis. Inclusion was not restricted by setting or participant age. Study selection, quality appraisal using the QUADAS-2 tool, and data extraction were conducted independently by two reviewers. Thereafter, narrative synthesis of included studies, and comparison of signatures performance, was performed.</ns4:p><ns4:p> </ns4:p><ns4:p> <ns4:bold>Results</ns4:bold></ns4:p><ns4:p> We screened 1,580 records and included 12 studies evaluating 31 host-blood transcriptomic signatures in 10 test or validation cohorts of PLHIV that differentiated individuals with TB from those with HIV alone, latent <ns4:italic>Mycobacterium tuberculosis</ns4:italic> infection, or other diseases (OD). Two (2/10; 20%) cohorts were prospective (29 TB cases; 51 OD) and 8 (80%) case-control (353 TB cases; 606 controls) design. All cohorts (10/10) were recruited in Sub-Saharan Africa and 9/10 (90%) had a high risk of bias. Ten signatures (10/31; 32%) met minimum WHO Target Product Profile (TPP) criteria for TB triage tests. Only one study (1/12; 8%) evaluated prognostic performance of a transcriptomic signature for progression to TB in PLHIV, which did not meet the minimum WHO prognostic TPP.</ns4:p><ns4:p> </ns4:p><ns4:p> <ns4:bold>Conclusions</ns4:bold></ns4:p><ns4:p> Generalisability of reported findings is limited by few studies enrolling PLHIV, limited geographical diversity, and predominantly case-control design, which also introduces spectrum bias. New prospective cohort studies are needed that include PLHIV and are conducted in diverse settings. Further research exploring the effect of HIV clinical, virological, and immunological factors on diagnostic performance is necessary for development and implementation of TB transcriptomic signatures in PLHIV.</ns4:p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"59 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135206595","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
Circumstances for treatment and control of invasive Enterobacterales infections in eight hospitals across sub-Saharan Africa: a cross-sectional study. 撒哈拉以南非洲8家医院侵袭性肠杆菌感染的治疗和控制情况:一项横断面研究
Pub Date : 2023-02-01 eCollection Date: 2023-01-01 DOI: 10.12688/gatesopenres.14267.1
Alexander M Aiken, Brian Nyamwaya, Lola Madrid, Dumessa Edessa, Appiah-Korang Labi, Noah Obeng-Nkrumah, William Mwabaya, Mabvuto Chimenya, Derek Cocker, Kenneth C Iregbu, Philip I P Princewill-Nwajiobi, Angela Dramowski, Tolbert Sonda, Blandina Theophil Mmbaga, David Ojok, Sombo Fwoloshi, J Anthony G Scott, Andrew Whitelaw

Background: Bloodstream infections caused by Enterobacterales show high frequency of antimicrobial resistance (AMR) in many Low- and Middle-Income Countries. We aimed to describe the variation in circumstances for management of such resistant infections in a group of African public-sector hospitals participating in a major research study. Methods: We gathered data from eight hospitals across sub-Saharan Africa to describe hospital services, infection prevention and antibiotic stewardship activities, using two WHO-generated tools. We collected monthly cross-sectional data on availability of antibiotics in the hospital pharmacies for bloodstream infections caused by Enterobacterales. We compared the availability of these antibiotics to actual patient-level use of antibiotics in confirmed Enterobacterales bloodstream infections (BSI). Results: Hospital circumstances for institutional management of resistant BSI varied markedly. This included self-evaluated infection prevention level (WHO-IPCAF score: median 428, range 155 to 687.5) and antibiotic stewardship activities (WHO stewardship toolkit questions: median 14.5, range 2 to 23). These results did not correlate with national income levels. Across all sites, ceftriaxone and ciprofloxacin were the most consistently available antibiotic agents, followed by amoxicillin, co-amoxiclav, gentamicin and co-trimoxazole. There was substantial variation in the availability of some antibiotics, especially carbapenems, amikacin and piperacillin-tazobactam with degree of access linked to national income level. Investigators described out-of-pocket payments for access to additional antibiotics at 7/8 sites. The in-pharmacy availability of antibiotics correlated well with actual use of antibiotics for treating BSI patients. Conclusions: There was wide variation between these African hospitals for a range of important circumstances relating to treatment and control of severe bacterial infections, though these did not all correspond to national income level. For most antibiotics, patient-level use reflected in-hospital drug availability, suggesting external antibiotics supply was infrequent. Antimicrobial resistant bacterial infections could plausibly show different clinical impacts across sub-Saharan Africa due to this contextual variation.

背景:在许多低收入和中等收入国家,肠杆菌引起的血液感染显示出高频率的抗微生物药物耐药性(AMR)。我们的目的是描述参与一项重大研究的一组非洲公立医院管理这种耐药感染情况的变化。方法:我们收集了撒哈拉以南非洲地区8家医院的数据,使用两种世卫组织生成的工具来描述医院服务、感染预防和抗生素管理活动。我们收集了每月医院药房用于肠杆菌引起的血流感染的抗生素可用性的横断面数据。我们比较了这些抗生素的可用性与确诊肠杆菌血液感染(BSI)患者实际使用抗生素的情况。结果:医院对耐药BSI的机构管理情况有显著差异。这包括自我评估感染预防水平(世卫组织- ipcaf评分:中位数428,范围155至687.5)和抗生素管理活动(世卫组织管理工具包问题:中位数14.5,范围2至23)。这些结果与国民收入水平无关。在所有地点,头孢曲松和环丙沙星是最稳定可用的抗生素,其次是阿莫西林、共阿莫昔拉夫、庆大霉素和共新诺明。某些抗生素,特别是碳青霉烯类、阿米卡星和哌拉西林-他唑巴坦的可得性存在很大差异,其可得程度与国民收入水平有关。调查人员在7/8个地点描述了自费获得额外抗生素的情况。药房内抗生素的可得性与治疗BSI患者的实际使用抗生素相关良好。结论:在与治疗和控制严重细菌感染有关的一系列重要情况下,这些非洲医院之间存在很大差异,尽管这些情况并不都符合国民收入水平。对于大多数抗生素,患者层面的使用反映了医院内药物的可用性,表明外部抗生素供应很少。由于这种背景差异,抗微生物药物耐药性细菌感染可能在撒哈拉以南非洲地区表现出不同的临床影响。
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引用次数: 0
Maré cohort-profile: a prospective cohort study based in a socially vulnerable community during the COVID-19 pandemic in Rio de Janeiro, Brazil mar<s:1>队列分析:一项基于巴西巴西里约热内卢2019冠状病毒病大流行期间社会弱势社区的前瞻性队列研究
Pub Date : 2023-02-01 DOI: 10.12688/gatesopenres.14035.1
Amanda A Batista-da-Silva, Olivia T Ranzani, Daniela M de Paulo, Mariana L Braunstein, Helena R Bozza, Ronald Fischer, Grazielle V Ramos, Carolina M C Dias, Everton P da Silva, Luna E Arouca, Leonardo L S Bastos, Otavio T Ranzani, S. Hamacher, Fernando A Bozza
Background: Socially vulnerable populations were vastly affected by the COVID-19 pandemic. The pandemic significantly impacted Brazil, pressuring its healthcare system for several months, with high mortality rates, even among the youngest population. Cohort studies combining disease surveillance are essential for understanding virus circulation in the community, surrogates of protection, vaccine effectiveness, and demand for health resources. Methods: Here, we present the protocol for a community-based prospective cohort study in the largest complex of favelas (slums) in Rio de Janeiro, Brazil (Complexo da Maré). The study participants are residents initially recruited during a massive vaccination campaign in the community. Five waves of data collection at approximately six-month intervals were planned. The first two waves have been completed at the time of writing this study protocol, and the third is underway. The protocol comprises interviews, blood sampling, and records linkage with secondary data to enrich the profiles of cohort participants and community information. We will describe COVID-19 seroprevalence, socio-demographic characteristics, and the burden of COVID-19, followed by estimating the association of socioeconomic factors and the burden of disease with seroprevalence. Discussion: The primary aims of the study are to assess COVID-19 clinical, epidemiological and genomic profiles and outcomes in residents from Maré, including vaccine effectiveness, surrogates of immune protection, virus transmission in households, and the overall burden of the pandemic.
背景:社会弱势群体受到COVID-19大流行的巨大影响。大流行对巴西造成了重大影响,对其医疗系统造成了数月的压力,死亡率很高,甚至在最年轻的人群中也是如此。结合疾病监测的队列研究对于了解病毒在社区中的传播、替代保护、疫苗有效性和对卫生资源的需求至关重要。方法:在这里,我们提出了一项基于社区的前瞻性队列研究方案,该研究在巴西里约热内卢最大的贫民窟(Complexo da mar)中进行。研究参与者最初是在社区大规模疫苗接种运动期间招募的居民。计划每隔大约六个月进行五波数据收集。在撰写本研究方案时,前两波已经完成,第三波正在进行中。该方案包括访谈、血液取样和与二手数据的记录联系,以丰富队列参与者的概况和社区信息。我们将描述COVID-19血清阳性率、社会人口统计学特征和COVID-19负担,然后估计社会经济因素和疾病负担与血清阳性率的关联。讨论:本研究的主要目的是评估mar居民的COVID-19临床、流行病学和基因组概况和结果,包括疫苗有效性、免疫保护替代品、病毒在家庭中的传播以及大流行的总体负担。
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引用次数: 0
A hybrid effectiveness-implementation study protocol to assess the effectiveness and chemoprevention efficacy of implementing seasonal malaria chemoprevention in five districts in Karamoja region, Uganda 有效性-实施混合研究方案,评估乌干达卡拉莫贾地区5个县实施季节性疟疾化学预防的有效性和化学预防效果
Pub Date : 2023-01-30 DOI: 10.12688/gatesopenres.14287.1
R. Kajubi, J. Ainsworth, K. Baker, S. Richardson, C. Bonnington, C. Rassi, Jane Achan, Godfrey Magumba, Denis Rubahika, Jane Nabakooza, J. Tibenderana, A. Nuwa, J. Opigo
Background: The World Health Organization (WHO) recommends seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine and amodiaquine for children aged 3 to 59 months, living in areas where malaria transmission is highly seasonal. However, due to widespread prevalence of resistance markers, SMC has not been implemented at scale in East and Southern Africa. An initial study in Uganda showed that SMC with SPAQ was feasible, acceptable, and protective against malaria in eligible children in Karamoja region. Nonetheless, exploration of alternative regimens is warranted since parasite resistance threats persist. Objective: The study aims to test the effectiveness of SMC with DP or SPAQ (DP-SMC & SPAQ-SMC), chemoprevention efficacy as well as the safety and tolerability of DP compared to that of SPAQ among 3-59 months old children in Karamoja region, an area of Uganda where malaria transmission is highly seasonal. Methods: A Type II hybrid effectiveness-implementation study design consisting of four components: 1) a cluster randomized controlled trial (cRCT) using passive surveillance to establish confirmed malaria cases in children using both SPAQ and DP; 2a) a prospective cohort study to determine the chemoprevention efficacy of SPAQ and DP (if SPAQ or DP clears sub-patent  infection and provides 28 days of protection from new infection) and whether drug concentrations and/or resistance influence the ability to clear and prevent infection; 2b) a sub study examining pharmacokinetics of DP in children between 3 to <6 months; 3) a resistance markers study in children 3–59 months in the research districts plus the standard intervention districts to measure changes in resistance marker prevalence over time and finally; 4) a process evaluation. Discussion: This study evaluates the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. Conclusion: This study will inform malaria policy in high-burden countries and contribute to progress in malaria control.
背景:世界卫生组织(世卫组织)建议对生活在疟疾传播高度季节性地区的3至59个月儿童使用磺胺多辛-乙胺嘧啶和阿莫地喹进行季节性疟疾化学预防(SMC)。然而,由于耐药标记物的广泛流行,SMC尚未在东非和南部非洲大规模实施。在乌干达进行的一项初步研究表明,在Karamoja地区,SMC结合SPAQ是可行的、可接受的,并且对符合条件的儿童具有预防疟疾的作用。尽管如此,由于寄生虫耐药性威胁持续存在,探索替代方案是有必要的。目的:在乌干达卡拉莫贾地区疟疾季节性传播较强的3-59月龄儿童中,检测SMC联合DP或SPAQ (DP-SMC & SPAQ-SMC)的有效性、化学预防效果以及DP与SPAQ的安全性和耐受性。方法:采用II型混合有效性-实施研究设计,包括四个组成部分:1)采用被动监测的聚类随机对照试验(cRCT),同时使用SPAQ和DP建立儿童疟疾确诊病例;2a)一项前瞻性队列研究,以确定SPAQ和DP的化学预防功效(如果SPAQ或DP清除亚专利感染并提供28天的新感染保护),以及药物浓度和/或耐药性是否影响清除和预防感染的能力;2b)一项检查3 - 6个月儿童DP药代动力学的亚研究;3)对研究区和标准干预区3 - 59月龄儿童进行耐药标志物研究,测量耐药标志物的流行率随时间的变化;4)过程评价。讨论:本研究在收集实施信息的同时评估临床干预对相关结果的影响。结论:本研究将为高负担国家的疟疾政策提供信息,并有助于疟疾控制的进展。
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引用次数: 0
A case for vaccinating adolescent girls for protection against COVID-19 during pregnancy and childbirth in resource-limited settings 在资源有限的环境中为少女接种疫苗以保护其在怀孕和分娩期间免受COVID-19侵害的案例
Pub Date : 2023-01-30 DOI: 10.12688/gatesopenres.13777.1
H. Blakeway, Lauren Hookham, E. Nakabembe, A. Koech, A. Khalil, S. Ladhani, M. Temmerman, K. Le Doare
The coronavirus disease 2019 (COVID-19) pandemic has had severe implications worldwide, including increased adverse maternal and neonatal health outcomes. Vaccination is one way of protecting against these adverse health outcomes. However, in some low-resource settings, vaccine inequity has led to poor uptake of COVID-19 vaccination. There are very high rates of adolescent pregnancy in low-resource settings, which are likely to become even higher as we begin to see the full effects of COVID-19 lockdown measures, including school closures. Although the benefits of COVID-19 vaccination in adolescents are debated, we propose that adolescent girls should be prioritised in COVID vaccination roll out in low-resource settings. This is to provide protection from severe COVID-19 disease in pregnancy, preventing adverse maternal and neonatal health outcomes.
2019年冠状病毒病(COVID-19)大流行在全球范围内产生了严重影响,包括孕产妇和新生儿健康不良后果增加。接种疫苗是预防这些不良健康后果的一种方法。然而,在一些资源匮乏的环境中,疫苗不平等导致COVID-19疫苗接种率低。在资源匮乏的环境中,青少年怀孕率非常高,随着我们开始看到包括学校关闭在内的COVID-19封锁措施的全面影响,这一比例可能会更高。尽管在青少年中接种COVID-19疫苗的益处存在争议,但我们建议,在资源匮乏的环境中,应优先考虑少女接种COVID-19疫苗。这是为了在怀孕期间预防COVID-19严重疾病,防止不良的孕产妇和新生儿健康结果。
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引用次数: 0
Adaptive strategies for the deployment of rapid diagnostic tests for COVID-19: a modelling study 部署COVID-19快速诊断检测的适应性策略:一项模型研究
Pub Date : 2023-01-27 DOI: 10.12688/gatesopenres.14202.1
Lucia Cilloni, E. Kendall, D. Dowdy, N. Arinaminpathy
Background: Lateral flow assays (LFAs) for the rapid detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) provide an affordable, rapid and decentralised means for diagnosing coronavirus disease 2019 (COVID-19). Concentrating on urban areas in low- and middle-income countries, we examined whether ‘dynamic’ screening algorithms, that adjust the use of confirmatory polymerase chain reaction (PCR) testing based on epidemiological conditions, could reduce cost without substantially reducing the impact of testing. Methods: Concentrating on a hypothetical ‘second wave’ of COVID-19 in India, we modelled the potential impact of testing 0.5% of the population per day at random with LFA, regardless of symptom status. We considered dynamic testing strategies where LFA positive cases are only confirmed with PCR when LFA positivity rates are below a given threshold (relative to the peak positive rate at the height of the epidemic wave), compared to confirming either all positive LFA results or confirming no results. Benefit was estimated based on cumulative incidence of infection, and resource requirements, based on the cumulative number of PCR tests used and the cumulative number of unnecessary isolations. Results: A dynamic strategy of discontinuing PCR confirmation when LFA positivity exceeded 50% of the peak positivity rate in an unmitigated epidemic would achieve comparable impact to one employing PCR confirmation throughout (9.2% of cumulative cases averted vs 9.8%), while requiring 35% as many PCR tests. However, the dynamic testing strategy would increase the number of false-positive test results substantially, from 0.07% of the population to 1.1%. Conclusions: Dynamic diagnostic strategies that adjust to epidemic conditions could help maximise the impact of testing at a given cost. Generally, dynamic strategies reduce the number of confirmatory PCR tests needed, but increase the number of unnecessary isolations. Optimal strategies will depend on whether greater priority is placed on limiting confirmatory testing or false-positive diagnoses.
背景:用于快速检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的侧流分析(LFA)为诊断2019冠状病毒病(新冠肺炎)提供了一种负担得起、快速和分散的手段。我们以中低收入国家的城市地区为重点,研究了“动态”筛查算法是否可以在不大幅降低检测影响的情况下降低成本,该算法根据流行病学条件调整确认聚合酶链式反应(PCR)检测的使用。方法:集中于假设的印度新冠肺炎“第二波”,我们模拟了每天用LFA随机检测0.5%人口的潜在影响,而不考虑症状状态。我们考虑了动态检测策略,即只有当LFA阳性率低于给定阈值(相对于疫情高峰时的峰值阳性率)时,才能通过PCR确认LFA阳性病例,而不是确认所有阳性LFA结果或确认无结果。根据累计感染率和资源需求,根据使用的PCR检测的累计次数和不必要隔离的累计次数,估计效益。结果:当LFA阳性率超过未缓解疫情中峰值阳性率的50%时,停止PCR确认的动态策略将产生与全程使用PCR确认的策略相当的影响(避免了9.2%的累计病例,而避免了9.8%),同时需要35%的PCR检测。然而,动态检测策略将大大增加假阳性检测结果的数量,从人口的0.07%增加到1.1%。结论:适应疫情条件的动态诊断策略可以帮助在给定成本下最大限度地提高检测的影响。一般来说,动态策略减少了所需的确认性PCR检测的数量,但增加了不必要的隔离数量。最佳策略将取决于是否更优先考虑限制验证性检测或假阳性诊断。
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引用次数: 0
Tranexamic acid for the prevention of postpartum bleeding: Protocol for a systematic review and individual patient data meta-analysis 氨甲环酸预防产后出血:系统评价方案和个体患者数据荟萃分析
Pub Date : 2023-01-19 DOI: 10.12688/gatesopenres.13747.1
Katharine Ker, Haleema Shakur-Still, Loïc Sentilhes, Luis D. Pacheco, George Saade, Catherine Deneux-Tharaux, Amy Brenner, Raoul Mansukhani, François-Xavier Ageron, Danielle Prowse, Rizwana Chaudhri, Oladapo Olayemi, Ian Roberts
Background: Tranexamic acid (TXA) reduces the risk of death and is recommended as a treatment for women with severe postpartum bleeding. There is hope that giving TXA shortly before or immediately after birth could prevent postpartum bleeding. Extending the use of TXA to prevent harmful postpartum bleeding could improve outcomes for millions of women; however, we must carefully consider the balance of benefits and potential harms. This article describes the protocol for a systematic review and individual patient data (IPD) meta-analysis to assess the effectiveness and safety of TXA for preventing postpartum bleeding, and to explore how the effects vary by underlying risk and other patient characteristics. Methods: We will search for prospectively registered, randomised controlled trials involving 500 patients or more assessing the effects of TXA in women giving birth. Two authors will extract data and assess risk of bias. IPD data will be sought from eligible trials. Primary outcomes will be life-threatening bleeding and thromboembolic events. We will use a one-stage model to analyse the data. Subgroup analyses will be conducted to explore whether the effectiveness and safety of TXA varies by underlying risk, type birth, maternal haemoglobin (Hb), and timing of TXA. Conclusions: This systematic review and IPD meta-analysis will address important clinical questions about the effectiveness and safety of the use of TXA for the prevention of postpartum bleeding that cannot be answered reliably using aggregate data and will inform the decision of who to treat. PROSPERO registration: CRD42022345775
背景:氨甲环酸(TXA)可降低死亡风险,被推荐用于重度产后出血妇女的治疗。有希望在分娩前不久或分娩后立即给予TXA可以防止产后出血。扩大使用TXA来预防有害的产后出血可以改善数百万妇女的结局;然而,我们必须仔细考虑利益和潜在危害的平衡。本文介绍了一项系统评价和个体患者数据(IPD)荟萃分析的方案,以评估TXA预防产后出血的有效性和安全性,并探讨其效果如何随潜在风险和其他患者特征而变化。方法:我们将检索前瞻性注册的随机对照试验,涉及500例或更多患者,评估TXA对分娩妇女的影响。两位作者将提取数据并评估偏倚风险。IPD数据将从符合条件的试验中寻求。主要结局将是危及生命的出血和血栓栓塞事件。我们将使用一个单阶段模型来分析数据。将进行亚组分析,以探讨TXA的有效性和安全性是否因潜在风险、出生类型、母体血红蛋白(Hb)和TXA的时间而变化。结论:本系统综述和IPD荟萃分析将解决有关使用TXA预防产后出血的有效性和安全性的重要临床问题,这些问题无法通过汇总数据可靠地回答,并将为决定谁治疗提供信息。普洛斯彼罗注册:CRD42022345775
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引用次数: 2
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Gates Open Research
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