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
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 Pa...
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| Format: | Journal Article |
| Language: | English |
| Published: |
2019
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| Subjects: | |
| Online Access: | https://hdl.handle.net/10356/90043 http://hdl.handle.net/10220/49350 |
| _version_ | 1826130151080984576 |
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| author | Wilder-Smith, Annelies Wei, Yinghui Araújo, Thalia Velho Barreto de VanKerkhove, Maria Martelli, Celina Maria Turchi Turchi, Marília Dalva Teixeira, Mauro Tami, Adriana Souza, João Sousa, Patricia Soriano-Arandes, Antoni Soria-Segarra, Carmen Clemente, Nuria Sanchez Rosenberger, Kerstin Daniela Reveiz, Ludovic Prata-Barbosa, Arnaldo Pomar, Léo Rosado, Luiza Emylce Pelá Perez, Freddy Passos, Saulo D. Nogueira, Mauricio Noel, Trevor P. Da Silva, Antônio Moura Moreira, Maria Elisabeth Morales, Ivonne Montoya, Maria Consuelo Miranda 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 Da Cunha, Antonio Alves Alger, Jackeline |
| author2 | Lee Kong Chian School of Medicine (LKCMedicine) |
| author_facet | Lee Kong Chian School of Medicine (LKCMedicine) Wilder-Smith, Annelies Wei, Yinghui Araújo, Thalia Velho Barreto de VanKerkhove, Maria Martelli, Celina Maria Turchi Turchi, Marília Dalva Teixeira, Mauro Tami, Adriana Souza, João Sousa, Patricia Soriano-Arandes, Antoni Soria-Segarra, Carmen Clemente, Nuria Sanchez Rosenberger, Kerstin Daniela Reveiz, Ludovic Prata-Barbosa, Arnaldo Pomar, Léo Rosado, Luiza Emylce Pelá Perez, Freddy Passos, Saulo D. Nogueira, Mauricio Noel, Trevor P. Da Silva, Antônio Moura Moreira, Maria Elisabeth Morales, Ivonne Montoya, Maria Consuelo Miranda 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 Da Cunha, Antonio Alves Alger, Jackeline |
| author_sort | Wilder-Smith, Annelies |
| collection | NTU |
| description | 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. |
| first_indexed | 2024-10-01T07:51:49Z |
| format | Journal Article |
| id | ntu-10356/90043 |
| institution | Nanyang Technological University |
| language | English |
| last_indexed | 2024-10-01T07:51:49Z |
| publishDate | 2019 |
| record_format | dspace |
| spelling | ntu-10356/900432020-11-01T05:29:27Z 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 Wei, Yinghui Araújo, Thalia Velho Barreto de VanKerkhove, Maria Martelli, Celina Maria Turchi Turchi, Marília Dalva Teixeira, Mauro Tami, Adriana Souza, João Sousa, Patricia Soriano-Arandes, Antoni Soria-Segarra, Carmen Clemente, Nuria Sanchez Rosenberger, Kerstin Daniela Reveiz, Ludovic Prata-Barbosa, Arnaldo Pomar, Léo Rosado, Luiza Emylce Pelá Perez, Freddy Passos, Saulo D. Nogueira, Mauricio Noel, Trevor P. Da Silva, Antônio Moura Moreira, Maria Elisabeth Morales, Ivonne Montoya, Maria Consuelo Miranda 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 Da Cunha, Antonio Alves Alger, Jackeline Lee Kong Chian School of Medicine (LKCMedicine) Science::Medicine ZIKV Congenital Zika Syndrome (CZS) 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. Published version 2019-07-16T02:33:03Z 2019-12-06T17:39:24Z 2019-07-16T02:33:03Z 2019-12-06T17:39:24Z 2019 Journal Article Wilder-Smith, A., Wei, Y., Da Araujo, T. V. B., VanKerkhove, M., Martelli, C. M. T., Turchi, M. D., . . . Alger, J. (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. BMJ Open, 9(6), e026092-. doi:10.1136/bmjopen-2018-026092 https://hdl.handle.net/10356/90043 http://hdl.handle.net/10220/49350 10.1136/bmjopen-2018-026092 en BMJ Open © 2019 Author(s). Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. 17 p. application/pdf |
| spellingShingle | Science::Medicine ZIKV Congenital Zika Syndrome (CZS) Wilder-Smith, Annelies Wei, Yinghui Araújo, Thalia Velho Barreto de VanKerkhove, Maria Martelli, Celina Maria Turchi Turchi, Marília Dalva Teixeira, Mauro Tami, Adriana Souza, João Sousa, Patricia Soriano-Arandes, Antoni Soria-Segarra, Carmen Clemente, Nuria Sanchez Rosenberger, Kerstin Daniela Reveiz, Ludovic Prata-Barbosa, Arnaldo Pomar, Léo Rosado, Luiza Emylce Pelá Perez, Freddy Passos, Saulo D. Nogueira, Mauricio Noel, Trevor P. Da Silva, Antônio Moura Moreira, Maria Elisabeth Morales, Ivonne Montoya, Maria Consuelo Miranda 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 Da Cunha, Antonio Alves Alger, Jackeline 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 |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Science::Medicine ZIKV Congenital Zika Syndrome (CZS) |
| url | https://hdl.handle.net/10356/90043 http://hdl.handle.net/10220/49350 |
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