{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,24]],"date-time":"2026-01-24T05:49:57Z","timestamp":1769233797386,"version":"3.49.0"},"reference-count":129,"publisher":"BMJ","issue":"6","funder":[{"DOI":"10.13039\/100004440","name":"Wellcome Trust","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004440","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,5,9]]},"published-print":{"date-parts":[[2019,6]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>PROSPERO International prospective register of systematic reviews (CRD42017068915).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2018-026092","type":"journal-article","created":{"date-parts":[[2019,6,19]],"date-time":"2019-06-19T06:25:13Z","timestamp":1560925513000},"page":"e026092","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":41,"title":["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"],"prefix":"10.1136","volume":"9","author":[{"given":"Annelies","family":"Wilder-Smith","sequence":"first","affiliation":[{"name":"Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yinghui","family":"Wei","sequence":"additional","affiliation":[{"name":"Centre for Mathematical Sciences, University of Plymouth, Plymouth, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thalia Velho Barreto de","family":"Ara\u00fajo","sequence":"additional","affiliation":[{"name":"Department of Social Medicine, Universidade Federal de Pernambuco, Recife, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"VanKerkhove","sequence":"additional","affiliation":[{"name":"Health Emergencies Programme, Organisation mondiale de la Sante, Geneve, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Celina Maria","family":"Turchi Martelli","sequence":"additional","affiliation":[{"name":"Department of Collective Health, Institute Aggeu Magalh\u00e3es (CPqAM), Oswaldo Cruz Foundation, Recife, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00edlia Dalva","family":"Turchi","sequence":"additional","affiliation":[{"name":"Institute of Tropical Pathology and Public Health, Federal University of Goias, Goi\u00e2nia, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mauro","family":"Teixeira","sequence":"additional","affiliation":[{"name":"Department of Biochemistry and Immunology, Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adriana","family":"Tami","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology, University Medical Center Groningen, Groningen, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jo\u00e3o","family":"Souza","sequence":"additional","affiliation":[{"name":"Department of Social Medicine, University of S\u00e3o Paulo, S\u00e3o Paulo, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia","family":"Sousa","sequence":"additional","affiliation":[{"name":"Reference Center for Neurodevelopment, Assistance, and Rehabilitation of Children, State Department of Health of Maranh\u00e3o, Sao Lu\u00eds, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antoni","family":"Soriano-Arandes","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University Hospital Vall d\u2019Hebron, Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carmen","family":"Soria-Segarra","sequence":"additional","affiliation":[{"name":"SOSECALI C. 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