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. Issue 6 (18th June 2019)

• Record Type: Journal Article
• Authors: Wilder-Smith, Annelies; Wei, Yinghui; Araújo, Thalia Velho Barreto de; VanKerkhove, Maria; Turchi Martelli, Celina Maria; Turchi, Marília Dalva; Teixeira, Mauro; Tami, Adriana; Souza, João; Sousa, Patricia; Soriano-Arandes, Antoni; Soria-Segarra, Carmen; Sanchez Clemente, Nuria; Rosenberger, Kerstin Daniela; Reveiz, Ludovic; Prata-Barbosa, Arnaldo; Pomar, Léo; Pelá Rosado, Luiza Emylce; Perez, Freddy; Passos, Saulo D.; Nogueira, Mauricio; Noel, Trevor P.; Moura da Silva, Antônio; Moreira, Maria Elisabeth; Morales, Ivonne; Miranda Montoya, Maria Consuelo; Miranda-Filho, Demócrito de Barros; Maxwell, Lauren; Macpherson, Calum N. L.; Low, Nicola; Lan, Zhiyi; LaBeaud, Angelle Desiree; Koopmans, Marion; Kim, Caron; João, Esaú; Jaenisch, Thomas; Hofer, Cristina Barroso; Gustafson, Paul; Gérardin, Patrick; Ganz, Jucelia S.; Dias, Ana Carolina Fialho; Elias, Vanessa; Duarte, Geraldo; Debray, Thomas Paul Alfons; Cafferata, María Luisa; Buekens, Pierre; Broutet, Nathalie; Brickley, Elizabeth B.; Brasil, Patrícia; Brant, Fátima; Bethencourt, Sarah; Benedetti, Andrea; Avelino-Silva, Vivian Lida; Ximenes, Ricardo Arraes de Alencar; Alves da Cunha, Antonio; Alger, Jackeline;
• Other Names: author non-byline.; Abreu de carvalho Liège Maria author non-byline.; Batista Rosangela author non-byline.; Bertozzi Ana Paula author non-byline.; Carles Gabriel author non-byline.; Cotrim Denise author non-byline.; Damasceno Luana author non-byline.; Dimitrakis Lady author non-byline.; Duarte rodrigues María Manoela author non-byline.; Estofolete Cassia F author non-byline.; Fragoso da silveira gouvêa Maria Isabel author non-byline.; Fumadó-pérez Vicky author non-byline.; Gazeta Rosa Estela author non-byline.; Kaydos-daniels Neely author non-byline.; Gilboa Suzanne author non-byline.; Krystosik Amy author non-byline.; Lambert Véronique author non-byline.; López-hortelano Milagros García author non-byline.; Mussi-pinhata Marisa Marcia author non-byline.; Nelson Christina author non-byline.; Nielsen Karin author non-byline.; Oliani Denise M author non-byline.; Rabello Renata author non-byline.; Ribeiro Marizelia author non-byline.; Rockx Barry author non-byline.; Rodrigues Laura C author non-byline.; Salgado Silvia author non-byline.; Silveira Katia author non-byline.; Sulleiro Elena author non-byline.; Tong Van author non-byline.; Valencia Diana author non-byline.; De souza Wayner Vieira author non-byline.; Villar centeno Luis Angel author non-byline.; Zin Andrea author non-byline.;
• Is Part Of: BMJ open. Volume 9:Issue 6(2019)
• Publication Date: 2019-06-18
• Subjects: individual participant data meta-analysisis -- prognosis -- congenital Zika syndrome -- Zika Virus -- Microcephaly -- risk prediction model; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2018-026092
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : 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 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 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. Trial registration number: PROSPERO International prospective register of systematic reviews (CRD42017068915).