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
Wilder-Smith, Annelies (Nanyang Technological University)
Wei, Yinghui (University of Plymouth)
de Araújo, Thalia Velho Barreto (Universidade Federal de Pernambuco)
VanKerkhove, Maria (Organisation mondiale de la Sante)
Turchi Martelli, Celina Maria (Fundação Oswaldo Cruz (Brasil))
Turchi, Marília Dalva (Federal University of Goias)
Teixeira, Mauro (Federal University of Minas Gerais)
Tami, Adriana (University Medical Center Groningen)
Souza, João (University of São Paulo)
Sousa, Patricia (State Department of Health of Maranhão)
Soriano-Arandes, Antoni (Hospital Universitari Vall d'Hebron)
Soria-Segarra, Carmen (SOSECALI C. Ltda)
Sanchez Clemente, Nuria (University of São Paulo)
Rosenberger, Kerstin Daniela (UniversitatsKlinikum Heidelberg)
Reveiz, Ludovic (Pan American Health Organization)
Prata-Barbosa, Arnaldo (D'Or Institute for Research & Education)
Pomar, Léo (Centre Hospitalier de l'Ouest Guyanais)
Pelá Rosado, Luiza Emylce (Goiânia State Health Secretary)
Perez, Freddy (Pan American Health Organization)
Passos, Saulo D. (FMJ)
Nogueira, Mauricio (Faculdade de Medicina de Sao Jose do Rio Preto)
Noel, Trevor P. (St. George's University)
Moura da Silva, Antônio (Universidade Federal do Maranhão - São Luís)
Moreira, Maria Elisabeth (Oswaldo Cruz Foundation (Fiocruz))
Morales, Ivonne (UniversitatsKlinikum Heidelberg)
Miranda Montoya, Maria Consuelo (Universidad Industrial de Santander (Colòmbia))
Miranda-Filho, Demócrito de Barros (University of Pernambuco)
Maxwell, Lauren (Emory University)
Macpherson, Calum N. L. (St. George's University)
Low, Nicola (University of Bern)
Lan, Zhiyi (McGill University)
LaBeaud, Angelle Desiree (Stanford Hospital)
Koopmans, Marion (Erasmus Medical Center)
Kim, Caron (World Health Organization)
João, Esaú (Hospital Federal dos Servidores do Estado)
Jaenisch, Thomas (UniversitatsKlinikum Heidelberg)
Hofer, Cristina Barroso (Universidade Federal do Rio de Janeiro)
Gustafson, Paul (University of British Columbia)
Gérardin, Patrick (Universite de la Reunion)
Ganz, Jucelia S. (Children's Hospital Juvencio Matos)
Dias, Ana Carolina Fialho (Federal University of Minas Gerais)
Elias, Vanessa (Pan American Health Organization)
Duarte, Geraldo (University of São Paulo)
Debray, Thomas Paul Alfons (University Medical Center Utrecht)
Cafferata, María Luisa (Instituto de Efectividad Clinica y Sanitaria)
Buekens, Pierre (Tulane University)
Broutet, Nathalie (World Health Organization)
Brickley, Elizabeth B. (London School of Hygiene and Tropical Medicine)
Brasil, Patrícia (Fundação Oswaldo Cruz (Brasil))
Brant, Fátima (Federal University of Minas Gerais)
Bethencourt, Sarah (Universidad de Carabobo)
Benedetti, Andrea (McGill University)
Avelino-Silva, Vivian Lida (Faculdade de Medicina da Universidade de Sao Paulo)
Ximenes, Ricardo Arraes de Alencar (Federal University of Pernambuco)
Alves da Cunha, Antonio (Federal University of Rio de Janeiro)
Alger, Jackeline (Universidad Nacional Autónoma de Honduras)
Universitat Autònoma de Barcelona

Fecha:	2019
Resumen:	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. We 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. 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. PROSPERO International prospective register of systematic reviews (CRD42017068915).
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Individual participant data meta-analysisis ; Prognosis ; Congenital Zika syndrome ; Zika Virus ; Microcephaly ; Risk prediction model
Publicado en:	BMJ open, Vol. 9 (june 2019) , ISSN 2044-6055

DOI: 10.1136/bmjopen-2018-026092
PMID: 31217315

17 p, 456.5 KB

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