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

被引：36

作者：

Wilder-Smith, Annelies ^{[1
]}

Wei, Yinghui ^{[2
]}

Barreto de Araujo, Thalia Velho ^{[3
]}

VanKerkhove, Maria ^{[4
]}

Turchi Martelli, Celina Maria ^{[5
]}

Turchi, Marilia Dalva ^{[6
]}

Teixeira, Mauro ^{[7
]}

Tami, Adriana ^{[8
]}

Souza, Joao ^{[9
]}

Sousa, Patricia ^{[10
]}

Soriano-Arandes, Antoni ^{[11
]}

Soria-Segarra, Carmen ^{[12
]}

Clemente, Nuria Sanchez ^{[13
]}

Rosenberger, Kerstin Daniela ^{[14
]}

Reveiz, Ludovic ^{[15
]}

Prata-Barbosa, Arnaldo ^{[16
]}

Pomar, Leo ^{[17
]}

Rosado, Luiza Emylce Pela ^{[18
]}

Perez, Freddy ^{[19
]}

Passos, Saulo D. ^{[20
]}

Nogueira, Mauricio ^{[21
]}

Noel, Trevor P. ^{[22
]}

da Silva, Antonio Moura ^{[23
]}

Moreira, Maria Elisabeth ^{[24
]}

Morales, Ivonne ^{[14
]}

Miranda Montoya, Maria Consuelo ^{[25
]}

Miranda-Filho, Democrito de Barros ^{[26
]}

Maxwell, Lauren ^{[27
,28
]}

Macpherson, Calum N. L. ^{[22
]}

Low, Nicola ^{[29
]}

Lan, Zhiyi ^{[30
]}

LaBeaud, Angelle Desiree ^{[31
]}

Koopmans, Marion ^{[32
]}

Kim, Caron ^{[33
]}

Joao, Esau ^{[34
]}

Jaenisch, Thomas ^{[14
]}

Hofer, Cristina Barroso ^{[35
]}

Gustafson, Paul ^{[36
]}

Gerardin, Patrick ^{[37
,38
]}

Ganz, Jucelia S. ^{[39
]}

Fialho Dias, Ana Carolina ^{[7
]}

Elias, Vanessa ^{[40
]}

Duarte, Geraldo ^{[41
]}

Alfons Debray, Thomas Paul ^{[42
]}

Cafferata, Maria Luisa ^{[43
]}

Buekens, Pierre ^{[44
]}

Broutet, Nathalie ^{[33
]}

Brickley, Elizabeth B. ^{[45
]}

Brasil, Patricia ^{[46
]}

Brant, Fatima ^{[7
]}

机构：

[1] Nanyang Technol Univ, Lee Kong Chian Sch Med, Singapore, Singapore

[2] Univ Plymouth, Ctr Math Sci, Plymouth, Devon, England

[3] Univ Fed Pernambuco, Dept Social Med, Recife, PE, Brazil

[4] WHO, Hlth Emergencies Programme, Geneva, Switzerland

[5] Fundacao Oswaldo Cruz, Inst Aggeu Magalhaes CPqAM, Dept Collect Hlth, Recife, PE, Brazil

[6] Univ Fed Goias, Inst Trop Pathol & Publ Hlth, Goiania, Go, Brazil

[7] Univ Fed Minas Gerais, Dept Biochem & Immunol, Belo Horizonte, MG, Brazil

[8] Univ Med Ctr Groningen, Dept Med Microbiol, Groningen, Netherlands

[9] Univ Sao Paulo, Dept Social Med, Sao Paulo, Brazil

[10] Reference Ctr Neurodev Assistance & Rehabil Child, State Dept Hlth Maranhao, Sao Luis, Maranhao, Brazil

[11] Univ Hosp Vall dHebron, Dept Pediat, Barcelona, Spain

[12] SOSECALI C Ltda, Guayaquil, Ecuador

[13] Univ Sao Paulo, Dept Epidemiol, Sao Paulo, Brazil

[14] Univ Klinikum Heidelberg, Dept Infect Dis, Sect Clin Trop Med, Heidelberg, Germany

[15] Pan Amer Hlth Org, Evidence & Intelligence Act Hlth, Washington, DC USA

[16] DOr Inst Res & Educ, Dept Pediat, Rio De Janeiro, Brazil

[17] Ctr Hosp Ouest Guyanais, Dept Obstet & Gynecol, St Laurent Du Maroni, French Guiana

[18] Goiania State Hlth Secretary, Hosp Materno Infantil Goiania, Goiania, Go, Brazil

[19] Pan Amer Hlth Org, Communicable Dis & Environm Determinants Hlth Dep, Washington, DC USA

[20] FMJ, Dept Pediat, Sao Paulo, Brazil

[21] Fac Med Sao Jose do Rio Preto, Dept Dermatol Dis, Sao Jose Do Rio Preto, Brazil

[22] St Georges Univ, Windward Isl Res & Educ Fdn, True Blue Point, Grenada

[23] Univ Fed Maranhao Sao Luis, Dept Publ Hlth, Sao Luis, Maranhao, Brazil

[24] Oswaldo Cruz Fdn Fiocruz, Dept Neonatol, Rio De Janeiro, Brazil

[25] Univ Ind Santander, Fac Salud, Bucaramanga, Colombia

[26] Univ Pernambuco, Fac Med Sci, Recife, PE, Brazil

[27] WHO, Reprod Hlth & Res, Geneva, Switzerland

[28] Emory Univ, Hubert Dept Global Hlth, Atlanta, GA 30322 USA

[29] Univ Bern, Inst Social & Prevent Med, Bern, Switzerland

[30] McGill Univ, Hlth Ctr, Montreal, PQ, Canada

[31] Stanford Hosp, Pediat Infect Dis, Palo Alto, CA USA

[32] Erasmus MC, Dept Virol, Rotterdam, Netherlands

[33] WHO, Dept Reprod Hlth & Res, Geneva, Switzerland

[34] Hosp Fed Servidores Estado, Dept Infect Dis, Rio De Janeiro, Brazil

[35] Univ Fed Rio de Janeiro, Inst Puericultura & Pediat Martagao Gesteira, Rio De Janeiro, Brazil

[36] Univ British Columbia, Stat, Vancouver, BC, Canada

[37] CHU La Reunion, INSERM, CIC1410, Clin Epidemiol, St Pierre, Reunion, France

[38] Univ la Reunion, UM PIMIT 134, CNRS 9192, INSERM U1187,IRD 249, St Clotilde, Reunion, France

[39] Childrens Hosp Juvencio Matos, Sao Luis, Maranhao, Brazil

[40] Pan Amer Hlth Org, Sustainable Dev & Environm Hlth, Washington, DC USA

[41] Univ Sao Paulo, Dept Gynecol & Obstet, Sao Paulo, Brazil

[42] Univ Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, Utrecht, Netherlands

[43] Inst Efectividad Clin & Sanitaria, Mother & Children Hlth Res Dept, Buenos Aires, DF, Argentina

[44] Tulane Univ, Sch Publ Hlth & Trop Med, New Orleans, LA USA

[45] London Sch Hyg & Trop Med, Dept Infect Dis Epidemiol, London, England

[46] Fundacao Oswaldo Cruz, Inst Pesquisa Clin Evandro Chagas, Rio De Janeiro, Brazil

[47] Univ Carabobo, Fac Ciencias Salud, Valencia, Venezuela

[48] McGill Univ, Dept Med, Montreal, PQ, Canada

[49] McGill Univ, Dept Epidemiol, Montreal, PQ, Canada

[50] McGill Univ, Dept Biostat, Montreal, PQ, Canada

来源：

BMJ OPEN | 2019年 / 9卷 / 06期

基金：

英国惠康基金;

关键词：

MULTIVARIATE METAANALYSIS; PREDICTION MODELS; PATIENT DATA; FRAMEWORK; DENGUE; ENHANCEMENT; PERFORMANCE; DIAGNOSIS; OUTBREAK; VACCINES;

D O I：

10.1136/bmjopen-2018-026092

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Introduction Zika 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 analysis We will identify eligible studies through the ZIKV IPD Consortium membership and a systematic review and invite study Pls 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 dissemination The 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.

引用

页数：17

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