The Zika Virus Individual Participant Data Consortium: A Global Initiative to Estimate the Effects of Exposure to Zika Virus during Pregnancy on Adverse Fetal, Infant, and Child Health Outcomes

This commentary describes the creation of the Zika Virus Individual Participant Data Consortium, a global collaboration to address outstanding questions in Zika virus (ZIKV) epidemiology through conducting an individual participant data meta-analysis (IPD-MA). The aims of the IPD-MA are to (1) estimate the absolute and relative risks of miscarriage, fetal loss, and short- and long-term sequelae of fetal exposure; (2) identify and quantify the relative importance of different sources of heterogeneity (e.g., immune profiles, concurrent flavivirus infection) for the risk of adverse fetal, infant, and child outcomes among infants exposed to ZIKV in utero; and (3) develop and validate a prognostic model for the early identification of high-risk pregnancies and inform communication between health care providers and their patients and public health interventions (e.g., vector control strategies, antenatal care, and family planning programs). By leveraging data from a diversity of populations across the world, the IPD-MA will provide a more precise estimate of the risk of adverse ZIKV-related outcomes within clinically relevant subgroups and a quantitative assessment of the generalizability of these estimates across populations and settings. The ZIKV IPD Consortium effort is indicative of the growing recognition that data sharing is a central component of global health security and outbreak response.

Download Full-text

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 ◽

10.1136/bmjopen-2018-026092 ◽

2019 ◽

Vol 9 (6) ◽

pp. e026092 ◽

Cited By ~ 9

Author(s):

Annelies Wilder-Smith ◽

Yinghui Wei ◽

Thalia Velho Barreto de Araújo ◽

Maria VanKerkhove ◽

Celina Maria Turchi Martelli ◽

...

Keyword(s):

Systematic Review ◽

Measurement Error ◽

Pregnant Women ◽

Longitudinal Studies ◽

Zika Virus ◽

Meta Analysis ◽

Child Outcomes ◽

Individual Participant Data ◽

Zikv Infection ◽

Individual Participant

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).

Download Full-text

Effects of behavioural parent training for children with attention-deficit/hyperactivity disorder on parenting behaviour: a protocol for an individual participant data meta-analysis

BMJ Open ◽

10.1136/bmjopen-2020-037749 ◽

2020 ◽

Vol 10 (11) ◽

pp. e037749

Author(s):

Laura Steenhuis ◽

Annabeth P Groenman ◽

Pieter J Hoekstra ◽

Rianne Hornstra ◽

Marjolein Luman ◽

...

Keyword(s):

Attention Deficit Hyperactivity Disorder ◽

Parent Training ◽

Parenting Stress ◽

Attention Deficit ◽

Meta Analysis ◽

Child Outcomes ◽

Individual Participant Data ◽

Hyperactivity Disorder ◽

Individual Participant ◽

Meta Analyses

IntroductionBehavioural parent training (BPT) is a well-established treatment for children with attention-deficit/hyperactivity disorder (ADHD). BPT is based on the hypothesis that improvements in parenting are mediators of improvements in children’s behaviours. However, meta-analyses show considerate heterogeneity in effects of BPT on child outcomes, and meta-analyses on parenting outcomes are scarce. Also, few studies have investigated parenting factors as mediators of child outcomes. This study aims to examine the effects and moderators of BPT on parenting outcomes and whether improvements in parenting mediate amelioration of behaviour and impairment in children with ADHD.Methods and analysesWe will conduct an individual participant data meta-analysis (IPDMA), making use of individual data of existing trials, and giving the opportunity for highly powered moderator analyses. This IPDMA will be performed by the Psychosocial ADHD INTervention (PAINT) collaboration. We will include randomised controlled trials of BPT, for individuals with ADHD below 18 years old. Systematic searches have been performed to locate relevant papers. Authors are currently contacted to share their data with the PAINT-IPDMA project. We will examine effects of BPT on parenting outcomes (eg, positive and negative parenting, management of affect, perceived parenting competence, parenting stress), moderators of these effects (eg, parental depression, parenting stress, severity of the child’s ADHD symptoms) and subsequently perform mediation analyses where parenting outcomes are modelled as mediators of child outcomes (eg, symptoms and severity of ADHD, comorbid psychopathology and impairment).Ethics and disseminationWe will include data from randomised control trials for which ethical approval has been received and consent forms have been signed. Deidentified data will be provided by the original investigators. We aim to disseminate our findings through peer-reviewed scientific journals, presentations at (inter)national scientific meetings, newsletters, the website of our project and the Dutch academic workspace ADHD.PROSPERO registration numberCRD42017069877.

Download Full-text