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.
Microcephaly
Zika Virus
congenital Zika syndrome
individual participant data meta-analysisis
prognosis
risk prediction model
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
18 06 2019
18 06 2019
Historique:
entrez:
21
6
2019
pubmed:
21
6
2019
medline:
2
7
2020
Statut:
epublish
Résumé
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).
Identifiants
pubmed: 31217315
pii: bmjopen-2018-026092
doi: 10.1136/bmjopen-2018-026092
pmc: PMC6588966
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e026092Subventions
Organisme : Wellcome Trust
Pays : United Kingdom
Organisme : World Health Organization
ID : 001
Pays : International
Organisme : NIAID NIH HHS
ID : R01 AI140718
Pays : United States
Organisme : Wellcome Trust
ID : 206532/Z/17/Z
Pays : United Kingdom
Investigateurs
Liège Maria Abreu de Carvalho
(LM)
Rosangela Batista
(R)
Ana Paula Bertozzi
(AP)
Gabriel Carles
(G)
Denise Cotrim
(D)
Luana Damasceno
(L)
Lady Dimitrakis
(L)
María Manoela Duarte Rodrigues
(MM)
Cassia F Estofolete
(CF)
Maria Isabel Fragoso da Silveira Gouvêa
(MI)
Vicky Fumadó-Pérez
(V)
Rosa Estela Gazeta
(RE)
Neely Kaydos-Daniels
(N)
Suzanne Gilboa
(S)
Amy Krystosik
(A)
Véronique Lambert
(V)
Milagros García López-Hortelano
(MG)
Marisa Marcia Mussi-Pinhata
(MM)
Christina Nelson
(C)
Karin Nielsen
(K)
Denise M Oliani
(DM)
Renata Rabello
(R)
Marizelia Ribeiro
(M)
Barry Rockx
(B)
Laura C Rodrigues
(LC)
Silvia Salgado
(S)
Katia Silveira
(K)
Elena Sulleiro
(E)
Van Tong
(V)
Diana Valencia
(D)
Wayner Vieira De Souza
(WV)
Luis Angel Villar Centeno
(LA)
Andrea Zin
(A)
Informations de copyright
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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