Understanding the relation between Zika virus infection during pregnancy and adverse fetal, infant and child outcomes: a protocol for a systematic review and individual participant data meta-analysis of longitudinal studies of pregnant women and their infants and children

IntroductionZika virus (ZIKV) infection during pregnancy is a known cause of microcephaly and other congenital and developmental anomalies. In the absence of a ZIKV vaccine or prophylactics, principal investigators (PIs) and international leaders in ZIKV research have formed the ZIKV Individual Participant Data (IPD) Consortium to identify, collect and synthesise IPD from longitudinal studies of pregnant women that measure ZIKV infection during pregnancy and fetal, infant or child outcomes.Methods and analysisWe will identify eligible studies through the ZIKV IPD Consortium membership and a systematic review and invite study PIs to participate in the IPD meta-analysis (IPD-MA). We will use the combined dataset to estimate the relative and absolute risk of congenital Zika syndrome (CZS), including microcephaly and late symptomatic congenital infections; identify and explore sources of heterogeneity in those estimates and develop and validate a risk prediction model to identify the pregnancies at the highest risk of CZS or adverse developmental outcomes. The variable accuracy of diagnostic assays and differences in exposure and outcome definitions means that included studies will have a higher level of systematic variability, a component of measurement error, than an IPD-MA of studies of an established pathogen. We will use expert testimony, existing internal and external diagnostic accuracy validation studies and laboratory external quality assessments to inform the distribution of measurement error in our models. We will apply both Bayesian and frequentist methods to directly account for these and other sources of uncertainty.Ethics and disseminationThe IPD-MA was deemed exempt from ethical review. We will convene a group of patient advocates to evaluate the ethical implications and utility of the risk stratification tool. Findings from these analyses will be shared via national and international conferences and through publication in open access, peer-reviewed journals.Trial registration numberPROSPERO International prospective register of systematic reviews (CRD42017068915).</jats:sec

Estudio de una cohorte de nacimientos de base poblacional en un área urbana desfavorecida de Río de Janeiro, Brasil: implementación y descripción de las características del estudio

Submitted by Janaína Nascimento ([email protected]) on 2019-07-04T01:45:01Z No. of bitstreams: 1 ve_Pedro_Renata_etal_INI_2019.pdf: 2377704 bytes, checksum: 66d55c9384941a43c97a5daee219bcc0 (MD5)Approved for entry into archive by Janaína Nascimento ([email protected]) on 2019-07-04T01:59:06Z (GMT) No. of bitstreams: 1 ve_Pedro_Renata_etal_INI_2019.pdf: 2377704 bytes, checksum: 66d55c9384941a43c97a5daee219bcc0 (MD5)Made available in DSpace on 2019-07-04T01:59:06Z (GMT). No. of bitstreams: 1 ve_Pedro_Renata_etal_INI_2019.pdf: 2377704 bytes, checksum: 66d55c9384941a43c97a5daee219bcc0 (MD5) Previous issue date: 2019Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Presidência. Programa de Computação Científica. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Núcleo Operacional Sentinela de Mosquitos Vetores. Rio de Janeiro, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.London School of Hygiene and Tropical Medicine. Department of Disease Control. London, U.K.Fundação Oswaldo Cruz. Núcleo Operacional Sentinela de Mosquitos Vetores. Rio de Janeiro, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil.A comprehensive cohort study including an entomological surveillance component can contribute to our knowledge of clinical aspects and transmission patterns of arbovirosis. This article describes the implementation of a populational-based birth cohort study that included an entomological surveillance component, and its associated challenges in a low-income community of Rio de Janeiro, Brazil. The participants were recruited in two periods: from 2012 to 2014, and from 2015 to 2017. The children had scheduled pediatric consultations and in case of fever. Epidemiological, clinical data and biological samples were collected at pediatric visits. Active febrile surveillance was performed by telephone calls, social networking, message apps, and household visits. A total of 387 newborns and 332 new children were included during the first and second recruitment periods, respectively. By July 2017, there were 451 children on follow-up. During the study, 2,759 pediatric visits were performed: 1,783 asymptomatic and 976 febrile/rash consultations. The number of febrile or rash consultations increased 3.5-fold after the use of media tools for surveillance. No temporal pattern, seasonality or peak of febrile cases was observed during the study period. A total of 10,105 adult mosquitoes (including 3,523 Aedes spp. and 6,582 Culex quinquefasciatus) and 46,047 Aedes eggs were collected from households, schools, and key sites. Although challenging, this structured sentinel populational-based birth cohort is relevant to the knowledge of risks and awareness of emerging pathogens