BMJ Open (Jun 2019)
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
- Lauren Maxwell,
- Gabriel Carles,
- Véronique Lambert,
- Arnaldo Prata-Barbosa,
- Laura C Rodrigues,
- Ludovic Reveiz,
- Annelies Wilder-Smith,
- Yinghui Wei,
- Thalia Velho Barreto de Araújo,
- Maria VanKerkhove,
- Celina Maria Turchi Martelli,
- Marília Dalva Turchi,
- Mauro Teixeira,
- Adriana Tami,
- João Souza,
- Patricia Sousa,
- Antoni Soriano-Arandes,
- Carmen Soria-Segarra,
- Kerstin Daniela Rosenberger,
- Léo Pomar,
- Luiza Emylce Pelá Rosado,
- Freddy Perez,
- Saulo D. Passos,
- Mauricio Nogueira,
- Trevor P. Noel,
- Antônio Moura da Silva,
- Maria Elisabeth Moreira,
- Ivonne Morales,
- Maria Consuelo Miranda Montoya,
- Calum N. L. Macpherson,
- Zhiyi Lan,
- Angelle Desiree LaBeaud,
- Marion Koopmans,
- Caron Kim,
- Esaú João,
- Thomas Jaenisch,
- Cristina Barroso Hofer,
- Patrick Gérardin,
- Jucelia S. Ganz,
- Ana Carolina Fialho Dias,
- Vanessa Elias,
- Geraldo Duarte,
- Thomas Paul Alfons Debray,
- María Luisa Cafferata,
- Pierre Buekens,
- Nathalie Broutet,
- Elizabeth B. Brickley,
- Patrícia Brasil,
- Fátima Brant,
- Sarah Bethencourt,
- Vivian Lida Avelino-Silva,
- Antonio Alves da Cunha,
- Jackeline Alger,
- Liège Maria Abreu de carvalho,
- Rosangela Batista,
- Ana Paula Bertozzi,
- Denise Cotrim,
- Luana Damasceno,
- Lady Dimitrakis,
- María Manoela Duarte rodrigues,
- Cassia F Estofolete,
- Maria Isabel Fragoso da silveira gouvêa,
- Vicky Fumadó-pérez,
- Neely Kaydos-daniels,
- Suzanne Gilboa,
- Amy Krystosik,
- Milagros García López-hortelano,
- Marisa Marcia Mussi-pinhata,
- Christina Nelson,
- Karin Nielsen,
- Denise M Oliani,
- Renata Rabello,
- Marizelia Ribeiro,
- Barry Rockx,
- Silvia Salgado,
- Katia Silveira,
- Elena Sulleiro,
- Van Tong,
- Diana Valencia,
- Wayner Vieira De souza,
- Luis Angel Villar centeno,
- Andrea Zin
Affiliations
- Lauren Maxwell
- Reproductive Health and Research, World Health Organization, Geneva, Switzerland
- Gabriel Carles
- From the Service de Gynécologie-obstétrique, Centre Hospitalier de l’ouest Guyanais, Saint Laurent du Maroni, French Guiana.
- Véronique Lambert
- Arnaldo Prata-Barbosa
- 5 Department of Pediatrics, School of Medicine, Universidade Federal do Rio de Janeiro (UFRJ) and D’Or Institute for Research & Education (IDOR), Rio de Janeiro, Brazil
- Laura C Rodrigues
- 1 IDE, London School of Hygiene & Tropical Medicine Faculty of Epidemiology and Population Health, London, UK
- Ludovic Reveiz
- 4 Knowledge Management, Bioethics, and Research Department, Pan American Health Organization, Washington, District of Columbia, USA
- Annelies Wilder-Smith
- Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore
- Yinghui Wei
- Centre for Mathematical Sciences, University of Plymouth, Plymouth, UK
- Thalia Velho Barreto de Araújo
- Department of Social Medicine, Universidade Federal de Pernambuco, Recife, Brazil
- Maria VanKerkhove
- Health Emergencies Programme, Organisation mondiale de la Sante, Geneve, Switzerland
- Celina Maria Turchi Martelli
- Department of Collective Health, Institute Aggeu Magalhães (CPqAM), Oswaldo Cruz Foundation, Recife, Brazil
- Marília Dalva Turchi
- Institute of Tropical Pathology and Public Health, Federal University of Goias, Goiânia, Brazil
- Mauro Teixeira
- Department of Biochemistry and Immunology, Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil
- Adriana Tami
- Department of Medical Microbiology, University Medical Center Groningen, Groningen, The Netherlands
- João Souza
- Department of Social Medicine, University of São Paulo, São Paulo, Brazil
- Patricia Sousa
- Reference Center for Neurodevelopment, Assistance, and Rehabilitation of Children, State Department of Health of Maranhão, Sao Luís, Brazil
- Antoni Soriano-Arandes
- Department of Pediatrics, University Hospital Vall d’Hebron, Barcelona, Spain
- Carmen Soria-Segarra
- SOSECALI C. Ltda, Guayaquil, Ecuador
- Kerstin Daniela Rosenberger
- Department of Infectious Diseases, Section Clinical Tropical Medicine, UniversitatsKlinikum Heidelberg, Heidelberg, Germany
- Léo Pomar
- Department of Obstetrics and Gynecology, Centre Hospitalier de l’Ouest Guyanais, Saint-Laurent du Maroni, French Guiana
- Luiza Emylce Pelá Rosado
- Hospital Materno Infantil de Goiânia, Goiânia State Health Secretary, Goiás, Brazil
- Freddy Perez
- Communicable Diseases and Environmental Determinants of Health Department, Pan American Health Organization, Washington, District of Columbia, USA
- Saulo D. Passos
- Department of Pediatrics, FMJ, São Paulo, Brazil
- Mauricio Nogueira
- Faculdade de Medicina de Sao Jose do Rio Preto, Department of Dermatologic Diseases, São José do Rio Preto, Brazil
- Trevor P. Noel
- Windward Islands Research and Education Foundation, St. George’s University, True Blue Point, Grenada
- Antônio Moura da Silva
- Department of Public Health, Universidade Federal do Maranhão – São Luís, São Luís, Brazil
- Maria Elisabeth Moreira
- Department of Neonatology, Oswaldo Cruz Foundation (Fiocruz), Rio de Janeiro, Brazil
- Ivonne Morales
- Department of Infectious Diseases, Section Clinical Tropical Medicine, UniversitatsKlinikum Heidelberg, Heidelberg, Germany
- Maria Consuelo Miranda Montoya
- Facultad de Salud, Universidad Industrial de Santander, Bucaramanga, Colombia
- Calum N. L. Macpherson
- Windward Islands Research and Education Foundation, St. George’s University, True Blue Point, Grenada
- Zhiyi Lan
- McGill University Health Centre, McGill University, Montréal, Canada
- Angelle Desiree LaBeaud
- Pediatric Infectious Diseases, Stanford Hospital, Palo Alto, California, USA
- Marion Koopmans
- Department of Virology, Erasmus Medical Center, Rotterdam, The Netherlands
- Caron Kim
- Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland
- Esaú João
- Department of Infectious Diseases, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil
- Thomas Jaenisch
- Department of Infectious Diseases, Section Clinical Tropical Medicine, UniversitatsKlinikum Heidelberg, Heidelberg, Germany
- Cristina Barroso Hofer
- Instituto de Puericultura e Pediatria Martagão Gesteira, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil
- Patrick Gérardin
- INSERM CIC1410 Clinical Epidemiology, CHU La Réunion, Saint Pierre, Réunion
- Jucelia S. Ganz
- Children’s Hospital Juvencio Matos, São Luís, Brazil
- Ana Carolina Fialho Dias
- Department of Biochemistry and Immunology, Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil
- Vanessa Elias
- Sustainable Development and Environmental Health, Pan American Health Organization, Washington, District of Columbia, USA
- Geraldo Duarte
- Department of Gynecology and Obstetrics, University of São Paulo, São Paulo, Brazil
- Thomas Paul Alfons Debray
- Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
- María Luisa Cafferata
- 2 Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina
- Pierre Buekens
- School of Public Health and Tropical Medicine, Tulane University, New Orleans, USA
- Nathalie Broutet
- medical officer
- Elizabeth B. Brickley
- Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK
- Patrícia Brasil
- Instituto de pesquisa Clínica Evandro Chagas, Fundacao Oswaldo Cruz, Rio de Janeiro, Brazil
- Fátima Brant
- Department of Biochemistry and Immunology, Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil
- Sarah Bethencourt
- Facultad de Ciencias de la Salud, Universidad de Carabobo, Valencia, Carabobo, Bolivarian Republic of Venezuela
- Vivian Lida Avelino-Silva
- Department of Infectious and Parasitic Diseases, Faculdade de Medicina da Universidade de Sao Paulo, São Paulo, Brazil
- Antonio Alves da Cunha
- Department of Pediatrics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil
- Jackeline Alger
- Facultad de Ciencias Médicas, Universidad Nacional Autónoma de Honduras, Tegucigalpa, Honduras
- Liège Maria Abreu de carvalho
- Rosangela Batista
- Ana Paula Bertozzi
- Denise Cotrim
- Luana Damasceno
- Lady Dimitrakis
- María Manoela Duarte rodrigues
- Cassia F Estofolete
- Maria Isabel Fragoso da silveira gouvêa
- Vicky Fumadó-pérez
- Neely Kaydos-daniels
- Suzanne Gilboa
- 3 Division of Congenital and Developmental Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
- Amy Krystosik
- Milagros García López-hortelano
- Marisa Marcia Mussi-pinhata
- Christina Nelson
- Karin Nielsen
- Denise M Oliani
- Renata Rabello
- Marizelia Ribeiro
- Barry Rockx
- Silvia Salgado
- Katia Silveira
- Elena Sulleiro
- Department of Microbiology, Vall d'Hebron University Hospital, Barcelona, Spain
- Van Tong
- 3 Division of Congenital and Developmental Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
- Diana Valencia
- Wayner Vieira De souza
- Luis Angel Villar centeno
- Andrea Zin
- 8Department of Clinical Research, Child and Maternal Health, Instituto Fernandes Figueira, Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil
- DOI
- https://doi.org/10.1136/bmjopen-2018-026092
- Journal volume & issue
-
Vol. 9,
no. 6
Abstract
IntroductionZika 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 analysisWe 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 disseminationThe 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 numberPROSPERO International prospective register of systematic reviews (CRD42017068915).
