Does health anxiety and vaccine concern predict self-reported adverse events following COVID-19 vaccination?-A Danish national cohort study.

Objectives: The nocebo effect refers to an expectation of sickness that leads to sickness in the expectant. Studies have found COVID-19 vaccines to be associated with the nocebo effect. However, the literature in this field is sparse yet important with the continuation of booster vaccines.

Effect of a campaign with oral polio vaccine on general health: A cluster-randomised trial in rural Guinea-Bissau.

Objectives: To investigate in a cluster-randomised trial whether a campaign with oral polio vaccine (C-OPV) reduced mortality and morbidity.

Methods: We randomised 222 village clusters under demographic surveillance to an intervention (health check and C-OPV) or control group (health check only). Children aged 0-8 months were eligible.

Contradictory mortality results in early 2-dose measles vaccine trials: interactions with oral polio vaccine may explain differences.

Objectives: Between 2003 and 2019, three trials (randomised controlled trials [RCTs]) in Guinea-Bissau randomised infants to an early 2-dose measles vaccine (MV) schedule at 4 and 9 months vs standard MV at 9 months. The RCTs produced contradictory mortality results; the effect being beneficial in the 2-dose group in the first but tending to have higher mortality in the last two RCTs. We hypothesised that increased frequency of campaigns with oral polio vaccine (C-OPV) explained the pattern.

COVID-19 vaccination and involuntary movements: A longitudinal panel study.

Objective: Despite high COVID-19 vaccination rates in many populations, concerns persist about potential adverse events, including concerns about involuntary movements. While case studies have shown occurrences of involuntary movements following COVID-19 vaccination, no systematic studies have explored this association. Our study aims to investigate the relationship between COVID-19 vaccination and involuntary movements.

Can earlier BCG-Japan and OPV vaccination reduce early infant mortality? A cluster-randomised trial in Guinea-Bissau.

Objective: To assess the effect of providing BCG and oral polio vaccine (OPV) at an early home visit after delivery.

Design: Cluster-randomised trial, randomising 92 geographically defined clusters 1:1 to intervention/control arms.

Setting: Bandim Health Project Health and Demographic Surveillance System, Guinea-Bissau.

Do Pentavalent (DTwP-Hib-HBV) vaccines have sex-differential nonspecific effects? An observational study.

Vaccines may alter the ability to combat infections unrelated to the target disease, i.e. have "nonspecific effects.

The association of vitamin K status with lung function and disease in a general population.

Introduction: Matrix Gla protein (MGP) is an inhibitor of lung tissue calcification. The plasma level of dephosphorylated-uncarboxylated MGP (dp-ucMGP) is a biomarker of vitamin K status. The present study assessed whether lower vitamin K status (reflected by higher dp-ucMGP) was associated with lung function and lung disease/symptoms.

Stillbirth and early neonatal mortality rates may be underestimated using recall information: A comparison of demographic surveillance methodologies.

Objective: Child mortality and stillbirth rates (SBR) remain high in low-income countries but may be underestimated due to incomplete reporting of child deaths in retrospective pregnancy/birth histories. The aim of this study is to compare stillbirth and mortality estimates derived using two different methods: the method assuming full information and the prospective method.

Methods: Bandim Health Project's Health and Demographic Surveillance Systems (HDSS) follows women of reproductive age and children under five through routine home visits every 1, 2 or 6 months.

Overall effect of a campaign with measles vaccine on the composite outcome mortality or hospital admission: A cluster-randomized trial among children aged 9-59 months in rural Guinea-Bissau.

Objectives: Campaigns with measles vaccine (C-MV) are conducted to eradicate measles, but prior studies indicate that MV reduces non-measles mortality and hospital admissions too. We hypothesized that C-MV reduces death/hospital admission by 30%.

Methods: Between 2016-2019, we conducted a non-blinded cluster-randomized trial randomizing village clusters in rural Guinea-Bissau to a C-MV targeting children aged 9-59 months.

Implications of Non-Specific Effects for Testing, Approving, and Regulating Vaccines.

The current framework for testing and regulating vaccines was established before the realization that vaccines, in addition to their effect against the vaccine-specific disease, may also have "non-specific effects" affecting the risk of unrelated diseases. Accumulating evidence from epidemiological studies shows that vaccines in some situations can affect all-cause mortality and morbidity in ways that are not explained by the prevention of the vaccine-targeted disease. Live attenuated vaccines have sometimes been associated with decreases in mortality and morbidity that are greater than anticipated.

Celiac disease and risk of neuropsychiatric disorders: A nationwide cohort study.

Introduction: Previous studies have indicated that patients with celiac disease (CD) may have an increased risk of developing neuropsychiatric disorders. However, large-scale epidemiologic studies on the topic are still scarce. We aimed to examine the association between CD and development of neuropsychiatric disorders during an 18-year follow-up period.

Can BCG vaccination at first health-facility contact reduce early infant mortality? Study protocol for a cluster-randomised trial (CS-BCG).

Introduction: Increasing evidence suggests that the BCG vaccine has non-specific effects, altering the susceptibility to non-tuberculous infections. Thus, early BCG vaccination may reduce mortality. BCG is recommended at birth but is often delayed.

Does Influenza Vaccination during Pregnancy Have Effects on Non-Influenza Infectious Morbidity? A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

The recommendation to provide inactivated influenza vaccine (IIV) to pregnant women is based on observed protection against influenza-related morbidity in mother and infant. Non-live vaccines may have non-specific effects (NSEs), increasing the risk of non-targeted infections in females. We reviewed the evidence from available randomised controlled trials (RCTs) of IIV to pregnant women, to assess whether IIV may have NSEs.

Impact of COVID-19 Disruptions on Global BCG Coverage and Paediatric TB Mortality: A Modelling Study.

The impact of COVID-19 disruptions on global Bacillus Calmette-Guérin (BCG) coverage and paediatric tuberculosis (TB) mortality is still unknown. To fill this evidence-gap and guide mitigation measures, we estimated the impact of COVID-19 disruptions on global BCG coverage and paediatric TB mortality. First, we used data from multiple sources to estimate COVID-19-disrupted BCG vaccination coverage.

Disregarding the restrictive vial-opening policy for BCG vaccine in Guinea-Bissau: impact and cost-effectiveness for tuberculosis mortality and all-cause mortality in children aged 0-4 years.

Objective: BCG vaccination is frequently delayed in low-income countries. Restrictive vial-opening policies, where a vial of BCG vaccine is not opened for few children, are a major reason for delay. During delays, children are unprotected against tuberculosis (TB) and deprived of non-specific effects of BCG.

The Association of Low Vitamin K Status with Mortality in a Cohort of 138 Hospitalized Patients with COVID-19.

It has recently been hypothesized that vitamin K could play a role in COVID-19. We aimed to test the hypotheses that low vitamin K status is a common characteristic of patients hospitalized with COVID-19 compared to population controls and that low vitamin K status predicts mortality in COVID-19 patients. In a cohort of 138 COVID-19 patients and 138 population controls, we measured plasma dephosphorylated-uncarboxylated Matrix Gla Protein (dp-ucMGP), which reflects the functional vitamin K status in peripheral tissue.

Factors associated with birthweight and adverse pregnancy outcomes among children in rural Guinea-Bissau - a prospective observational study.

Background: Low birthweight (LBW) is associated with higher mortality and morbidity, but there is limited data on the prevalence of LBW in rural Africa, where many births occur at home. The Bacillus Calmette-Guérin (BCG) vaccine has non-specific effects. Studies suggest that maternal BCG-vaccination may affect the health of the child.

Neonatal and child mortality data in retrospective population-based surveys compared with prospective demographic surveillance: EN-INDEPTH study.

Background: Global mortality estimates remain heavily dependent on household surveys in low- and middle-income countries, where most under-five deaths occur. Few studies have assessed the accuracy of mortality data or determinants of capturing births in surveys.

Methods: The Every Newborn-INDEPTH study (EN-INDEPTH) included a large, multi-country survey of women aged 15-49 interviewed about livebirths and their survival status in five Health and Demographic Surveillance Systems (HDSSs).

Termination of pregnancy data completeness and feasibility in population-based surveys: EN-INDEPTH study.

Background: Termination of pregnancy (TOP) is a common cause of maternal morbidity and mortality in low- and middle-income countries. Population-based surveys are the major data source for TOP data in LMICs but are known to have shortcomings that require improving. The EN-INDEPTH multi-country survey employed a full pregnancy history approach with roster and new questions on TOP and Menstrual Restoration.

Electronic data collection in a multi-site population-based survey: EN-INDEPTH study.

Background: Electronic data collection is increasingly used for household surveys, but factors influencing design and implementation have not been widely studied. The Every Newborn-INDEPTH (EN-INDEPTH) study was a multi-site survey using electronic data collection in five INDEPTH health and demographic surveillance system sites.

Methods: We described experiences and learning involved in the design and implementation of the EN-INDEPTH survey, and undertook six focus group discussions with field and research team to explore their experiences.

Paradata analyses to inform population-based survey capture of pregnancy outcomes: EN-INDEPTH study.

Background: Paradata are (timestamped) records tracking the process of (electronic) data collection. We analysed paradata from a large household survey of questions capturing pregnancy outcomes to assess performance (timing and correction processes). We examined how paradata can be used to inform and improve questionnaire design and survey implementation in nationally representative household surveys, the major source for maternal and newborn health data worldwide.

Pregnancy intention data completeness, quality and utility in population-based surveys: EN-INDEPTH study.

Background: An estimated 40% of pregnancies globally are unintended. Measurement of pregnancy intention in low- and middle-income countries relies heavily on surveys, notably Demographic and Health Surveys (DHS), yet few studies have evaluated survey questions. We examined questions for measuring pregnancy intention, which are already in the DHS, and additional questions and investigated associations with maternity care utilisation and adverse pregnancy outcomes.