What Research Questions Should the Next Generation of Birth Cohort Studies Address? An International Delphi Study of Experts.

OBJECTIVE: Birth cohort studies (BCS) have generated a wealth of invaluable basic scientific and policy-relevant information on a wide range of issues in child health and development. This study sought to explore what research questions are currently a priority for the next generation of BCS using a 3-round Delphi survey of interdisciplinary experts. METHODS: Twenty-four (Round I, N = 17; Round II, N = 21; Round III, N = 18) experts across a wide range of fields (eg, psychology, public health, and maternal/child health) agreed to participate. In Round I, the expert panel was invited to freely respond to the question, "what are the key scientific questions future birth cohort studies should address?" Content analysis of answers was used to identify 47 questions for rating on perceived importance by the panel in Round II and consensus-achieving questions were identified. Questions that did not reach consensus in Round II were posed again for expert re-rating in Round III. RESULTS: Twenty six of 47 questions reached consensus in Round II, with an additional 6 reaching consensus in Round III. Consensus-achieving questions rated highly on importance spanned a number of topics, including environmental effects on child development, intergenerational transmission of disadvantage, and designing BCS to inform intervention strategies. CONCLUSION: Investigating the effects of family/environmental factors and social disadvantage on a child's development should be prioritized in designing future BCS. The panel also recommended that future BCS are designed to inform intervention strategies

Evidence for Better Lives Study: a comparative birth-cohort study on child exposure to violence and other adversities in eight low- and middle-income countries - foundational research (study protocol)

Funder: Consuelo Zobel Alger Foundation, Inc.Funder: British Academy; FundRef: http://dx.doi.org/10.13039/501100000286Funder: Cambridge Humanities Research Grants SchemeFunder: University of Cambridge GCRF Quality ResearchFunder: Jacobs Foundation; FundRef: http://dx.doi.org/10.13039/501100003986Funder: Wolfson discretionary researchIntroduction: Violence against children is a health, human rights and social problem affecting approximately half of the world’s children. Its effects begin at prenatal stages with long-lasting impacts on later health and well-being. The Evidence for Better Lives Study (EBLS) aims to produce high-quality longitudinal data from cities in eight low- and middle-income countries—Ghana, Jamaica, Pakistan, the Philippines, Romania, South Africa, Sri Lanka and Vietnam—to support effective intervention to reduce violence against children. EBLS-Foundational Research (EBLS-FR) tests critical aspects of the planned EBLS, including participant recruitment and retention, data collection and analysis. Alongside epidemiological estimates of levels and predictors of exposure to violence and adversity during pregnancy, we plan to explore mechanisms that may link exposure to violence to mothers’ biological stress markers and subjective well-being. Methods and analyses: EBLS-FR is a short longitudinal study with a sample of 1200 pregnant women. Data are collected during the last trimester of pregnancy and 2 to 6 months after birth. The questionnaire for participating women has been translated into nine languages. Measures obtained from mothers will include, among others, mental and physical health, attitudes to corporal punishment, adverse childhood experiences, prenatal intimate partner violence, substance use and social/community support. Hair and dry blood spot samples are collected from the pregnant women to measure stress markers. To explore research participation among fathers, EBLS-FR is recruiting 300 fathers in the Philippines and Sri Lanka. Ethics and dissemination: The study received ethical approvals at all recruiting sites and universities in the project. Results will be disseminated through journal publications, conferences and seminar presentations involving local communities, health services and other stakeholders. Findings from this work will help to adjust the subsequent stages of the EBLS project

Perceived stress during the prenatal period: assessing measurement invariance of the Perceived Stress Scale (PSS-10) across cultures and birth parity

Maternal prenatal stress places a substantial burden on mother’s mental health. Expectant mothers in low- and middle-income countries (LMICs) have thus far received less attention than mothers in high-income settings. This is particularly problematic, as a range of triggers, such as exposure to traumatic events (e.g. natural disasters, previous pregnancy losses) and adverse life circumstances (e.g. poverty, community violence), put mothers at increased risk of experiencing prenatal stress. The ten-item Perceived Stress Scale (PSS-10) is a widely recognised index of subjective experience of stress that is increasingly used in LMICs. However, evidence for its measurement equivalence across settings is lacking. This study aims to assess measurement invariance of the PSS-10 across eight LMICs and across birth parity. This research was carried out as part of the Evidence for Better Lives Study (EBLS, vrc.crim.cam.ac.uk/vrcresearch/EBLS). The PSS-10 was administered to N = 1,208 expectant mothers from Ghana, Jamaica, Pakistan, the Philippines, Romania, South Africa, Sri Lanka and Vietnam during the third trimester of pregnancy. Confirmatory factor analysis suggested a good model fit of a two-factor model across all sites, with items on experiences of stress loading onto a negative factor and items on perceived coping onto a positive factor. Configural and metric, but not full or partial scalar invariance, were established across all sites. Configural, metric and full scalar invariance could be established across birth parity. On average, first-time mothers reported less stress than mothers who already had children. Our findings indicate that the PSS-10 holds utility in assessing stress across a broad range of culturally diverse settings; however, caution should be taken when comparing mean stress levels across sites

Prenatal attachment: using measurement invariance to test the validity of comparisons across eight culturally diverse countries

Funder: Jacobs Foundation; doi: http://dx.doi.org/10.13039/501100003986Funder: the Consuelo Zobel Alger FoundationFunder: The British AcademyFunder: the Cambridge Humanities Research Grants SchemeFunder: the University of Edinburgh College Office for the College of ArtsFunder: the Wolfson Professor of Criminology Discretionary FundAbstract: Studies in high-income countries (HICs) have shown that variability in maternal-fetal attachment (MFA) predict important maternal health and child outcomes. However, the validity of MFA ratings in low- and middle-income countries (LMICs) remains unknown. Addressing this gap, we assessed measurement invariance to test the conceptual equivalence of the Prenatal Attachment Inventory (PAI: Muller, 1993) across eight LMICs. Our aim was to determine whether the PAI yields similar information from pregnant women across different cultural contexts. We administered the 18-item PAI to 1181 mothers in the third trimester (Mean age = 28.27 years old, SD = 5.81 years, range = 18–48 years) expecting their first infant (n = 359) or a later-born infant (n = 820) as part of a prospective birth cohort study involving eight middle-income countries: Ghana, Jamaica, Pakistan, Philippines, Romania, South Africa, Sri Lanka and Vietnam. We used Multiple Group Confirmatory Factor Analyses to assess across-site measurement invariance. A single latent factor with partial measurement invariance was found across all sites except Pakistan. Group comparisons showed that mean levels of MFA were lowest for expectant mothers in Vietnam and highest for expectant mothers in Sri Lanka. MFA was higher in first-time mothers than in mothers expecting a later-born child. The PAI yields similar information about MFA across culturally distinct middle-income countries. These findings strengthen confidence in the use of the tool across different settings; future studies should explore the use of the PAI as a screen for maternal behaviour that place children at risk

Correction to: Prenatal attachment: Using measurement invariance to test the validity of comparisons across eight culturally diverse countries.

A Correction to this paper has been published: https://doi.org/10.1007/s00737-021-01122-7Fondation Botna

Efficacy of a tetravalent dengue vaccine in healthy children aged 4–16 years: a randomised, placebo-controlled, phase 3 trial

Background: A substantial unmet need remains for safe and effective vaccines against dengue virus disease, particularly for individuals who are dengue-naive and those younger than 9 years. We aimed to assess the efficacy, safety, and immunogenicity of a live attenuated tetravalent dengue vaccine (TAK-003) in healthy children aged 4-16 years. Methods: We present data up to 18 months post-vaccination from an ongoing phase 3, randomised, double-blind trial of TAK-003 in endemic regions of Asia and Latin America (26 medical and research centres across Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka, and Thailand). Healthy children aged 4-16 years were randomly assigned 2:1 (stratified by age and region) to receive two doses of TAK-003 or two doses of placebo, 3 months apart. Investigators, participants and their parents or guardians, and sponsor representatives advising on trial conduct were masked to trial group assignments. Participants presenting with febrile illness were tested for virologically confirmed dengue (VCD) by serotype-specific RT-PCR. In timeframes beginning 30 days post-second dose, the primary endpoint (overall vaccine efficacy) was assessed in the first 11 months, and the secondary endpoints (efficacy by baseline serostatus, serotype, hospitalised dengue, and severe dengue) in the first 17 months. This study is registered with ClinicalTrials.gov, NCT02747927. Findings: 20 099 participants were randomly assigned and vaccinated between Sept 7, 2016, and Aug 18, 2017; 19 021 (94·6%) were included in the per protocol analysis, and 20 071 (99·9%) in the safety set. The primary endpoint was achieved with an overall vaccine efficacy of 80·2% (95% CI 73·3 to 85·3; 61 cases of VCD in the TAK-003 group vs 149 cases of VCD in the placebo group). In the secondary endpoint assessment timeframe, an overall vaccine efficacy of 73·3% (95% CI 66·5 to 78·8) was observed. Analysis of secondary endpoints showed efficacies of 76·1% (95% CI 68·5 to 81·9) in individuals who were seropositive at baseline, 66·2% (49·1 to 77·5) in individuals who were seronegative at baseline, 90·4% (82·6 to 94·7) against hospitalised dengue, and 85·9% (31·9 to 97·1) against dengue haemorrhagic fever. Efficacy varied by individual serotypes (DENV 1, 69·8% [95% CI 54·8 to 79·9]; DENV 2, 95·1% [89·9 to 97·6]; DENV 3, 48·9% [27·2 to 64·1]; DENV 4, 51·0% [-69·4 to 85·8]). Cumulative rates of serious adverse events were similar in TAK-003 (4·0%) and placebo (4·8%) recipients, and were consistent with expected medical disorders in the study population. Infection was the most frequent reason leading to serious adverse events. 20 participants (\u3c0·1% of the safety set) were withdrawn from the trial due to 21 adverse events by the end of part two; 14 of these participants received TAK-003 and six received placebo. Interpretation: TAK-003 was well tolerated and efficacious against symptomatic dengue in children regardless of serostatus before immunisation. Vaccine efficacy varied by serotype, warranting continued follow-up to assess longer-term vaccine performance. Funding: Takeda Vaccines

The Intergenerational Effects of Intimate Partner Violence in Pregnancy: Mediating Pathways and Implications for Prevention

Intimate partner violence during pregnancy (P-IPV) can have significant adverse impacts on both mother and foetus. Existing P-IPV interventions rightly focus on the safety of the mother and reducing re-victimisation; yet expanding these to address the adverse impact on the foetus has considerable potential for preventing long term negative developmental outcomes. In this review, we draw together evidence on major pathways linking exposure to P-IPV and child outcomes. Using a narrative review of 105 articles, we discuss candidate pathways linking P-IPV to child outcomes, as well as their implications for intervention. Articles were identified via keyword searches of social science and medical databases and by inspection of reference lists of the most relevant articles, including recent reviews and meta-analyses. Articles were included if they addressed issues relevant to understanding the effects of P-IPV on child outcomes via five core pathways: maternal stress and mental illness, foetal attachment, health problems and health-related behaviours. We also included articles relevant for linking these pathways to P-IPV interventions. We conclude that developing comprehensive P-IPV interventions that target immediate risk to the mother as well as long-term child outcomes have significant potential to help reduce the global burden of P-IPV

The Intergenerational Effects of Intimate Partner Violence in Pregnancy: Mediating Pathways and Implications for Prevention

Intimate partner violence during pregnancy (P-IPV) can have significant adverse impacts on both mother and foetus. Existing P-IPV interventions rightly focus on the safety of the mother and reducing re-victimisation; yet expanding these to address the adverse impact on the foetus has considerable potential for preventing long term negative developmental outcomes. In this review, we draw together evidence on major pathways linking exposure to P-IPV and child outcomes. Using a narrative review of 105 articles, we discuss candidate pathways linking P-IPV to child outcomes, as well as their implications for intervention. Articles were identified via keyword searches of social science and medical databases and by inspection of reference lists of the most relevant articles, including recent reviews and meta-analyses. Articles were included if they addressed issues relevant to understanding the effects of P-IPV on child outcomes via five core pathways: maternal stress and mental illness, foetal attachment, health problems and health-related behaviours. We also included articles relevant for linking these pathways to P-IPV interventions. We conclude that developing comprehensive P-IPV interventions that target immediate risk to the mother as well as long-term child outcomes have significant potential to help reduce the global burden of P-IPV

The Intergenerational Effects of Intimate Partner Violence in Pregnancy: Mediating Pathways and Implications for Prevention

Prenatal intimate partner violence (P-IPV) can have significant adverse impacts on both mother and fetus. Existing P-IPV interventions focus on the safety of the mother and on reducing revictimization; yet expanding these to address the adverse impact on the fetus has considerable potential for preventing long-term negative developmental outcomes. In this review, we draw together evidence on major pathways linking exposure to P-IPV and child outcomes, arguing that these pathways represent potential targets to improve P-IPV intervention efforts. Using a narrative review of 112 articles, we discuss candidate pathways linking P-IPV to child outcomes, as well as their implications for intervention. Articles were identified via key word searches of social science and medical databases and by inspection of reference lists of the most relevant articles, including recent reviews and meta-analyses. Articles were included if they addressed issues relevant to understanding the effects of P-IPV on child outcomes via six core pathways: maternal stress and mental illness, maternal–fetal attachment, maternal substance use, maternal nutritional intake, maternal antenatal health-care utilization, and infection. We also included articles relevant for linking these pathways to P-IPV interventions. We conclude that developing comprehensive P-IPV interventions that target immediate risk to the mother as well as long-term child outcomes via the candidate mediating pathways identified have significant potential to help reduce the global burden of P-IPV.</p