[CF Lung Disease - a German S3 Guideline: Pseudomonas aeruginosa]. / S3-Leitlinie: Lungenerkrankung bei Mukoviszidose ­ Pseudomonas aeruginosa.

Cystic Fibrosis (CF) is the most common autosomal recessive genetic multisystemic disease. In Germany, it affects at least 8000 people. The disease is caused by mutations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene leading to dysfunction of CFTR, a transmembrane chloride channel. This defect causes insufficient hydration of the airway epithelial lining fluid which leads to reduction of the mucociliary clearance.Even if highly effective, CFTR modulator therapy has been available for some years and people with CF are getting much older than before, recurrent and chronic infections of the airways as well as pulmonary exacerbations still occur. In adult CF life, Pseudomonas aeruginosa (PA) is the most relevant pathogen in colonisation and chronic infection of the lung, leading to further loss of lung function. There are many possibilities to treat PA-infection.This is a S3-clinical guideline which implements a definition for chronic PA-infection and demonstrates evidence-based diagnostic methods and medical treatment in order to give guidance for individual treatment options.

Psychometrics of psychosocial behavior items under age 6 years: Evidence from Nebraska, USA.

Because healthy psychosocial development in the first years of life is critical to lifelong well-being, governmental, and nongovernmental organizations are increasingly interested in monitoring psychosocial behaviors among populations of children. In response, the World Health Organization is developing the Global Scales of Early Development Psychosocial Form (GSED PF) to facilitate population-level psychosocial monitoring. Once validated, the GSED PF will be an open-access, caregiver-reported measure of children's psychosocial behaviors that is appropriate for infants and young children. This study examines the psychometric validity evidence from 45 items under consideration for inclusion in the GSED PF. Using data from N = 836 Nebraskan (USA) children aged 180 days to 71 months, results indicate that scores from 44 of the 45 (98%) items exhibit positive evidence of validity and reliability. A bifactor model with one general factor and five specific factors best fit the data, exhibited strong reliability, and acceptable model fit. Criterion associations with known predictors of children's psychosocial behaviors were in the expected direction. These findings suggest that measurement of children's psychosocial behaviors may be feasible, at least in the United States. Data from more culturally and linguistically diverse settings is needed to assess these items for global monitoring.

Debido a que el desarrollo sicosocial en los primeros años de vida es crítico para el bienestar de toda la vida, las organizaciones gubernamentales y no gubernamentales están más y más interesadas en observar vigilantemente las conductas sicosociales en la población infantil. Como respuesta, la Organización Mundial de la Salud está desarrollando el Formulario Sicosocial de las Escalas Globales del Temprano Desarrollo (GSED PF) para facilitar la observación sicosocial alerta al nivel del grupo de población. Una vez que se haya convalidado, el GSED PF será una medida de acceso abierto, que reportará el cuidador, sobre las conductas sicosociales de los niños que son apropiadas para infantes y niños pequeñitos. Este estudio examina la evidencia de la validez sicométrica de 45 puntos bajo consideración para ser incluidos en el GSED PF. Usando datos de N = 836 niños de Nebraska (Estados Unidos), de edad entre 180 días y 71 meses, los resultados indican que los puntajes de 44 de los 45 (98%) puntos muestran evidencia positiva de validez y confiabilidad. Un modelo bifactorial con un factor general y cinco factores específicos, que mejor encaja con los datos, mostró una fuerte confiabilidad y un modelo aceptable que encaja. Las asociaciones de criterio con factores de predicción conocidos acerca de las conductas sicosociales de los niños se encontraban en la dirección esperada. Estos resultados sugieren que la medida de las conductas sicosociales de los niños pudiera ser posible, por lo menos en los Estados Unidos. Se necesitan datos de escenarios más diversos cultural y lingüísticamente para evaluar estos puntos para la estar alerta en la observación global.

Maternal obesity and childhood asthma risk: Exploring mediating pathways.

BACKGROUND: Growing evidence for the effect of maternal obesity on childhood asthma motivates investigation of mediating pathways. OBJECTIVE: To investigate if childhood body mass index (BMI), gestational weight gain (GWG) and preterm birth mediate the association of maternal obesity on childhood asthma risk. METHODS: We used electronic medical records from mother-child pairs enrolled in Kaiser Permanente Northern California integrated healthcare system. Children were followed from their birth (2005-2014) until at least age 4 (n = 95,723), age 6 (n = 59,230) or age 8 (n = 25,261). Childhood asthma diagnosis at each age was determined using ICD-9/10 codes and medication dispensings. Prepregnancy BMI (underweight [<18.5], normal [18.5-24.9], overweight [25-29.9], obese [≥30] kg/m2 ) were defined using height and weight measurements close to the last menstrual period date. Child's BMI (Centers for Disease Control and Prevention BMI-for-age percentiles: underweight [<5th], normal [5th-85th], overweight [85th-95th], obese [>95th]) were obtained using anthropometric measurements taken the year preceding each follow-up age. GWG (delivery weight-prepregnancy weight) was categorised based on Institutes of Medicine recommendations (inadequate, adequate, excessive). Implementing first causal inference test (CIT) then causal mediator models (to decompose the natural direct and indirect effects), we examined the potential mediating effect of childhood BMI, GWG, and preterm birth on the association between prepregnancy BMI (continuous and categorical) and childhood asthma. RESULTS: Overall, risk of childhood asthma increased as prepregnancy BMI increased (age 4 risk ratio: 1.07, 95% confidence interval: 1.04, 1.09, per 5 kg/m2 increase in BMI; similar for age 6 and 8). CIT identified childhood BMI and preterm birth, but not GWG as potential mediators. Causal mediation models confirmed childhood BMI, but not preterm birth, as having a partial mediating effect. Results were similar for age 6 and 8, and when continuous mediators (instead of binary) were assessed. CONCLUSIONS: Childhood overweight/obesity has a modest mediating effect on the association between prepregnancy BMI and childhood asthma.

In-Hospital Formula Feeding Hindered Exclusive Breastfeeding: Breastfeeding Self-Efficacy as a Mediating Factor.

Breastfeeding self-efficacy (BSE), defined as a mother's confidence in her ability to breastfeed, has been confirmed to predict the uptake of exclusive breastfeeding (EBF). Early experiences during the birth hospital stay, especially in-hospital formula feeding (IHFF), can impact both EBF and maternal breastfeeding confidence. Therefore, our objective was to examine the association between IHFF and EBF outcomes and investigate whether this association is influenced by BSE. The study included 778 infants from a larger cohort study conducted in 2021, with a one-year follow-up in rural areas of Sichuan Province, China. We used a causal mediation analysis to estimate the total effect (TE), natural direct (NDE), and nature indirect effects (NIE) using the paramed command in Stata. Causal mediation analyses revealed that IHFF was negatively associated with EBF (TE odds ratio = 0.47; 95% CI, 0.29 to 0.76); 28% of this association was mediated by BSE. In the subgroup analysis, there were no significant differences in the effects between parity subgroups, as well as between infant delivery subgroups. Our study found that IHFF hindered later EBF and that BSE mediated this association. Limiting the occurrence of in-hospital formula feeding or improving maternal breastfeeding self-efficacy is likely to improve exclusive breastfeeding outcomes.

The 2023 Impact of Inflammatory Bowel Disease in Canada: The Influence of Sex and Gender on Canadians Living With Inflammatory Bowel Disease.

Sex (the physical and physiologic effects resulting from having specific combinations of sex chromosomes) and gender (sex-associated behaviours, expectations, identities, and roles) significantly affect the course of inflammatory bowel disease (IBD) and the experience of living with IBD. Sex-influenced physiologic states, like puberty, the menstrual cycle, pregnancy, and andropause/menopause may also impact and be impacted by IBD. While neither Crohn's disease nor ulcerative colitis is commonly considered sex-determined illnesses, the relative incidence of Crohn's disease and ulcerative colitis between males and females varies over the life cycle. In terms of gender, women tend to use healthcare resources at slightly higher rates than men and are more likely to have fragmented care. Women are more commonly prescribed opioid medications and are less likely than men to undergo colectomy. Women tend to report lower quality of life and have higher indirect costs due to higher rates of disability. Women are also more likely to take on caregiver roles for children with IBD. Women with IBD are more commonly burdened with adverse mental health concerns and having poor mental health has a more profound impact on women than men. Pregnant people with active IBD have higher rates of adverse outcomes in pregnancy, made worse in regions with poor access to IBD specialist care. The majority of individuals with IBD in Canada do not have access to a pregnancy-in-IBD specialist; access to this type of care has been shown to allay fears and increase knowledge among pregnant people with IBD.

Associations of in-hospital postpartum feeding experiences with exclusive breastfeeding practices among infants in rural Sichuan, China.

BACKGROUND: In rural China, exclusive breastfeeding (EBF) prevalence is low and hospitals often fail to attain baby-friendly feeding objectives, such as ≥ 75% of newborns exclusively breastfed from birth to discharge. Empirical evidence for the impact of increased hospital compliance with recommended feeding guidelines on continued EBF in rural China is lacking. We sought to measure and model the association of newborns' in-hospital feeding experiences with EBF practice in infancy to inform policies for EBF promotion. METHODS: Data were cross-sectional from 785 caregivers of infants < 6 months of age, collected from November to December 2019 in four underdeveloped counties/districts in Sichuan Province. In-hospital feeding practices were determined, and prevalence of current infant feeding practices was calculated from 24-h recall and categorized according to WHO/UNICEF Infant and Young Child Feeding categories as EBF, breastfed with non-milk liquids, mixed feeding, breastfed with solids, and not breastfed. Relative risk ratios were estimated using adjusted multinomial logistic regression to examine risk factors for non-EBF practices compared to EBF, including in-hospital feeding experiences. The regression model was used to investigate change in EBF prevalence under alternative in-hospital experiences. RESULTS: Only 38.1% of under-six-month-old infants were being exclusively breastfed when data were collected; 61.8% and 77.6% had been fed water and infant formula, respectively, in the hospital. Infants who were fed water or formula before discharge were estimated as 2-3 times as likely to be non-EBF than EBF up to age six months. According to our model, EBF prevalence would have increased to 53.7% (95% confidence interval (CI) 46.1, 61.2) had ≥ 75% of infants been exclusively breastfed and water-based feeds eliminated in-hospital. CONCLUSIONS: Given the importance of infants' first feeding experiences in the establishment and continuation of EBF, it is imperative that rural Chinese hospitals actively seek to limit infant formula feeds to medically indicated situations and eliminate water-based feeds.

Smartphone-based point-of-care anemia screening in rural Bihar in India.

BACKGROUND: The high prevalence of anemia in resource-constrained settings calls for easy-to-use, inexpensive screening tools. The Sanguina Smartphone App, an innovative tool for non-invasive hemoglobin estimation via color-sensitive, algorithm-based analysis of fingernail bed images, was validated in the United States. This study evaluates the performance of the App in a population with different socio-economic, ethnic, demographic and cultural composition in rural Bihar, India. METHODS: For 272 mainly adult patients of a private health centre, hemoglobin measurement with the App is compared with the gold standard laboratory blood analysis. For a second sample of 179 children attending pre-schools, hemoglobin measurement with the App is compared to the results of the HemoCue Hb 301, a point-of-care device using a small blood sample, serving as the reference standard for field-based settings. RESULTS: The App reaches ±4.43 g/dl accuracy and 0.38 g/dl bias of comparator values in the clinic-based sample, and ±3.54 g/dl and 1.30 g/dl, respectively in the pre-school sample. After retraining the algorithm with the collected data, the validity of the upgraded version is retested showing an improved performance (accuracy of ±2.25 g/dl, bias of 0.25 g/dl), corresponding to the results of the original validation study from the United States. CONCLUSIONS: The initial version of the App does not achieve the accuracy needed for diagnosis or screening. After retraining the algorithm, it achieves an accuracy sufficient for screening. The improved version with the potential for further adaptions is a promising easy-to-use, inexpensive screening tool for anemia in resource-constrained point-of-care settings.

Hemoglobin is a protein in the blood that is required to move oxygen around the body. Anemia is a condition that occurs when levels of hemoglobin are too low. Anemia can lead to serious problems with the heart and lungs. This study assesses the accuracy of using a Smartphone App to measure hemoglobin levels by taking photos of a person's nails in rural Bihar, India. Results from the App are compared with those obtained by measuring hemoglobin in blood samples. Initially, measurements of hemoglobin obtained using the App were inaccurate, however when the App was modified using data from some of the people in India, the App was more accurate. This study shows that the App can and should be adapted for use in different populations and can enable anemia to be diagnosed outside of hospitals and other healthcare settings.

The creation of the Global Scales for Early Development (GSED) for children aged 0-3 years: combining subject matter expert judgements with big data.

INTRODUCTION: With the ratification of the Sustainable Development Goals, there is an increased emphasis on early childhood development (ECD) and well-being. The WHO led Global Scales for Early Development (GSED) project aims to provide population and programmatic level measures of ECD for 0-3 years that are valid, reliable and have psychometrically stable performance across geographical, cultural and language contexts. This paper reports on the creation of two measures: (1) the GSED Short Form (GSED-SF)-a caregiver reported measure for population-evaluation-self-administered with no training required and (2) the GSED Long Form (GSED-LF)-a directly administered/observed measure for programmatic evaluation-administered by a trained professional. METHODS: We selected 807 psychometrically best-performing items using a Rasch measurement model from an ECD measurement databank which comprised 66 075 children assessed on 2211 items from 18 ECD measures in 32 countries. From 766 of these items, in-depth subject matter expert judgements were gathered to inform final item selection. Specifically collected were data on (1) conceptual matches between pairs of items originating from different measures, (2) developmental domain(s) measured by each item and (3) perceptions of feasibility of administration of each item in diverse contexts. Prototypes were finalised through a combination of psychometric performance evaluation and expert consensus to optimally identify items. RESULTS: We created the GSED-SF (139 items) and GSED-LF (157 items) for tablet-based and paper-based assessments, with an optimal set of items that fit the Rasch model, met subject matter expert criteria, avoided conceptual overlap, covered multiple domains of child development and were feasible to implement across diverse settings. CONCLUSIONS: State-of-the-art quantitative and qualitative procedures were used to select of theoretically relevant and globally feasible items representing child development for children aged 0-3 years. GSED-SF and GSED-LF will be piloted and validated in children across diverse cultural, demographic, social and language contexts for global use.

Effect of the mHealth-supported Healthy Future programme delivered by community health workers on maternal and child health in rural China: study protocol for a cluster randomised controlled trial.

INTRODUCTION: Millions of young rural children in China still suffer from poor health and malnutrition, partly due to a lack of knowledge about optimal perinatal and child care among rural mothers and caregivers. Meanwhile, there is an urgent need to improve maternal mental health in rural communities. Comprehensive home visiting programmes delivered by community health workers (CHWs) can bridge the caregiver knowledge gap and improve child health and maternal well-being in low-resource settings, but the effectiveness of this approach is unknown in rural China. Additionally, grandmothers play important roles in child care and family decision-making in rural China, suggesting the importance of engaging multiple caregivers in interventions. The Healthy Future programme seeks to improve child health and maternal well-being by developing a staged-based curriculum that CHWs deliver to mothers and caregivers of young children through home visits with the assistance of a tablet-based mHealth system. This protocol describes the design and evaluation plan for this programme. METHODS AND ANALYSIS: We designed a cluster-randomised controlled trial among 119 rural townships in four nationally designated poverty counties in Southwestern China. We will compare the outcomes between three arms: one standard arm with only primary caregivers participating in the intervention, one encouragement arm engaging primary and secondary caregivers and one control arm with no intervention. Families with pregnant women or infants under 6 months of age are invited to enrol in the 12-month study. Primary outcomes include children's haemoglobin levels, exclusive breastfeeding rates and dietary diversity in complementary feeding. Secondary outcomes include a combination of health, behavioural and intermediate outcomes. ETHICS AND DISSEMINATION: Ethical approval has been provided by Stanford University, Sichuan University and the University of Nevada, Reno. Trial findings will be disseminated through national and international peer-reviewed publications and conferences. TRIAL REGISTRATION NUMBER: ISRCTN16800789.

Protocol for validation of the Global Scales for Early Development (GSED) for children under 3 years of age in seven countries.

INTRODUCTION: Children's early development is affected by caregiving experiences, with lifelong health and well-being implications. Governments and civil societies need population-based measures to monitor children's early development and ensure that children receive the care needed to thrive. To this end, the WHO developed the Global Scales for Early Development (GSED) to measure children's early development up to 3 years of age. The GSED includes three measures for population and programmatic level measurement: (1) short form (SF) (caregiver report), (2) long form (LF) (direct administration) and (3) psychosocial form (PF) (caregiver report). The primary aim of this protocol is to validate the GSED SF and LF. Secondary aims are to create preliminary reference scores for the GSED SF and LF, validate an adaptive testing algorithm and assess the feasibility and preliminary validity of the GSED PF. METHODS AND ANALYSIS: We will conduct the validation in seven countries (Bangladesh, Brazil, Côte d'Ivoire, Pakistan, The Netherlands, People's Republic of China, United Republic of Tanzania), varying in geography, language, culture and income through a 1-year prospective design, combining cross-sectional and longitudinal methods with 1248 children per site, stratified by age and sex. The GSED generates an innovative common metric (Developmental Score: D-score) using the Rasch model and a Development for Age Z-score (DAZ). We will evaluate six psychometric properties of the GSED SF and LF: concurrent validity, predictive validity at 6 months, convergent and discriminant validity, and test-retest and inter-rater reliability. We will evaluate measurement invariance by comparing differential item functioning and differential test functioning across sites. ETHICS AND DISSEMINATION: This study has received ethical approval from the WHO (protocol GSED validation 004583 20.04.2020) and approval in each site. Study results will be disseminated through webinars and publications from WHO, international organisations, academic journals and conference proceedings. REGISTRATION DETAILS: Open Science Framework https://osf.io/ on 19 November 2021 (DOI 10.17605/OSF.IO/KX5T7; identifier: osf-registrations-kx5t7-v1).

Trends in the prevalence and social determinants of stunting in India, 2005-2021: findings from three rounds of the National Family Health Survey.

Objectives: To assess social determinants of stunting and the shifts in contributions of socio-demographic factors to national prevalence trends in India between 2005 and 2021. Methods: We leveraged data from three rounds of the National Family Health Survey (NFHS-3: 2005-2006, NFHS-4: 2015-2016, NFHS-5: 2019-2021) for 443 038 children under 5 years. Adjusted logistic regression models and a Kitigawa-Oaxaca-Blinder decomposition were deployed to examine how wealth, residence, belonging to a marginalised social group, maternal education and child sex contributed to changes in stunting prevalence. Results: The decrease in stunting prevalence was notably slower between NFHS-4 and NFHS-5 (annual average rate of reduction (AARR): 1.33%) than between NFHS-3 and NFHS-4 (AARR: 2.20%). The protective effect of high wealth diminished from 2015 onwards but persisted for high maternal education. However, an intersection of higher household wealth and maternal education mitigated stunting to a greater extent than either factor in isolation. Residence only predicted stunting in 2005-2006 with an urban disadvantage (adjusted OR: 1.18; 95% CI: 1.07 to 1.29). Children from marginalised social groups displayed increased likelihoods of stunting, from 6-16% in 2005-2006 to 11-21% in 2015-2016 and 2020-2021. Being male was associated with 6% and 7% increased odds of stunting in 2015-2016 and 2019-2021, respectively. Increased household wealth (45%) and maternal education (14%) contributed to decreased stunting prevalence between 2005 and 2021. Conclusions: Stunting prevalence in India has decreased across social groups. However, social disparities in stunting persist and are exacerbated by intersections of low household wealth, maternal education and being from a marginalised social group. Increased survival must be accompanied by needs-based interventions to support children and mitigate mutually reinforcing sources of inequality.

Rapid Evolution of a Fragment-like Molecule to Pan-Metallo-Beta-Lactamase Inhibitors: Initial Leads toward Clinical Candidates.

With the emergence and rapid spreading of NDM-1 and existence of clinically relevant VIM-1 and IMP-1, discovery of pan inhibitors targeting metallo-beta-lactamases (MBLs) became critical in our battle against bacterial infection. Concurrent with our fragment and high-throughput screenings, we performed a knowledge-based search of known metallo-beta-lactamase inhibitors (MBLIs) to identify starting points for early engagement of medicinal chemistry. A class of compounds exemplified by 11, discovered earlier as B. fragilis metallo-beta-lactamase inhibitors, was selected for in silico virtual screening. From these efforts, compound 12 was identified with activity against NDM-1 only. Initial exploration on metal binding design followed by structure-guided optimization led to the discovery of a series of compounds represented by 23 with a pan MBL inhibition profile. In in vivo studies, compound 23 in combination with imipenem (IPM) robustly lowered the bacterial burden in a murine infection model and became the lead for the invention of MBLI clinical candidates.

Social normative origins of the taboo gap and implications for adolescent risk for HIV infection in Zambia.

Zambian Demographic and Health Survey data reveal that increased discordance between professed attitudes and measures of behaviour regarding premarital sex among adults is strongly associated with increased risk of HIV in adolescents, particularly girls. We hypothesised that this was due to the reluctance to talk about premarital sex, resulting in a situation we call the "taboo gap" where sexual behaviour is a forbidden topic and adolescents feel unable to seek advice or sexual and reproductive health services. Our analysis revealed that the taboo gap is rooted in harmful gender norms that are perpetuated by schools, churches, cultural influences, development programmes and health systems. Challenges like food insecurity and household poverty may place girls in positions where they are vulnerable to sexual exploitation, increasing their risk of exposure to HIV. Unmarried adolescents, particularly girls, report being ridiculed when they go to reproductive health clinics, which discourages them from seeking care in the future. Strengthening peer support and parent-child interactions are important programmatic elements. We conclude that discordance serves as a novel measure and harbinger for the presence of gender norms which generated a taboo gap that impeded carseeking and increased risk for HIV among adolescents, especially girls, in Zambia. We propose that successful interventions must involve a multifaceted, gender transformative approach which engages peers and stakeholders in schools, churches, clinics, and families, particularly parents, to reduce the gendered gap in HIV risk and transmission.

Preventive small-quantity lipid-based nutrient supplements reduce severe wasting and severe stunting among young children: an individual participant data meta-analysis of randomized controlled trials.

BACKGROUND: Meta-analyses show that small-quantity lipid-based nutrient supplements (SQ-LNSs) reduce child wasting and stunting. There is little information regarding effects on severe wasting or stunting. OBJECTIVES: We aimed to identify the effect of SQ-LNSs on prevalence of severe wasting (weight-for-length z score < -3) and severe stunting (length-for-age z score < -3). METHODS: We conducted a 2-stage meta-analysis of individual participant data from 14 randomized controlled trials of SQ-LNSs provided to children 6-24 mo of age. We generated study-specific and subgroup estimates of SQ-LNS compared with control and pooled the estimates using fixed-effects models. We used random-effects meta-regression to examine study-level effect modifiers. In sensitivity analyses, we examined whether results differed depending on study arm inclusion criteria and types of comparisons. RESULTS: SQ-LNS provision led to a relative reduction of 31% in severe wasting [prevalence ratio (PR): 0.69; 95% CI: 0.55, 0.86; n = 34,373] and 17% in severe stunting (PR: 0.83; 95% CI: 0.78, 0.90; n = 36,795) at endline. Results were similar in most of the sensitivity analyses but somewhat attenuated when comparisons using passive control arms were excluded (PR: 0.74; 95% CI: 0.57, 0.96; n = 26,327 for severe wasting and PR: 0.88; 95% CI: 0.81, 0.95; n = 28,742 for severe stunting). Study-level characteristics generally did not significantly modify the effects of SQ-LNSs, but results suggested greater effects of SQ-LNSs in sites with greater burdens of wasting or stunting, or with poorer water quality or sanitation. CONCLUSIONS: Including SQ-LNSs in preventive interventions to promote healthy child growth and development is likely to reduce rates of severe wasting and stunting. This meta-analysis was registered at www.crd.york.ac.uk/PROSPERO as CRD42019146592.

Effect of imbalanced sampling and missing data on associations between gender norms and risk of adolescent HIV.

Background: Despite strides towards gender equality, inequalities persist or remain unstudied, due potentially to data gaps. Although mapped, the effects of key data gaps remain unknown. This study provides a framework to measure effects of gender- and age-imbalanced and missing covariate data on gender-health research. The framework is demonstrated using a previously studied pathway for effects of pre-marital sex norms among adults on adolescent HIV risk. Methods: After identifying gender-age-imbalanced Demographic and Health Survey (DHS) datasets, we resampled responses and restricted covariate data from a relatively complete, balanced dataset derived from the 2007 Zambian DHS to replicate imbalanced gender-age sampling and covariate missingness. Differences in model outcomes due to sampling were measured using tests for interaction. Missing covariate effects were measured by comparing fully-adjusted and reduced model fitness. Findings: We simulated data from 25 DHS surveys across 20 countries from 2005-2014 on four sex-stratified models for pathways of adult attitude-behaviour discordance regarding pre-marital sex and adolescent risk of HIV. On average, across gender-age-imbalanced surveys, males comprised 29.6% of responses compared to 45.3% in the gender-balanced dataset. Gender-age-imbalanced sampling significantly affected regression coefficients in 40% of model-scenarios (N = 40 of 100) and biased relative-risk estimates away from gender-age-balanced sampling outcomes in 46% (N = 46) of model-scenarios. Model fitness was robust to covariate removal with minor effects on male HIV models. No consistent trends were observed between sampling distribution and risk of biased outcomes. Interpretation: Gender-health model outcomes may be affected by sampling gender-age-imbalanced data and less-so by missing covariates. Although occasionally attenuated, the effect magnitude of gender-age-imbalanced sampling is variable and may mask true associations, thus misinforming policy dialogue. We recommend future surveys improve balanced gender-age sampling to promote research reliability. Funding: Bill & Melinda Gates Foundation grant OPP1140262 to Stanford University.

Gender Norms and Gender Equality in Full-Time Employment and Health: A 97-Country Analysis of the World Values Survey.

Background: Almost nowhere in the world do women participate as much as men in the labor force. Despite differences in countries' economic, social and cultural contexts, gender norms-unwritten rules of acceptable actions for men and women-have been found to affect women's labor participation across contexts. Gender norms include those regulating who takes care of children, who is expected to earn more, and in which sectors men and women should work. Importantly, norms affect access to labor markets at times of scarcity: when there's only work for one, gender norms can dictate whether a woman or man gets the job. Advocates of equal labor force participation point to evidence that employment can contribute to people's health and well-being; yet the evidence is mixed and contradictory, and mostly comes from high-income countries. In restrictive normative contexts in which women are assigned the role of family caretaker, full time employment (FTE) might be particularly burdensome. At the same time, the literature lacks a cross-country analysis of how gender norms affect women's FTE and their health when employed full time, despite qualitative research providing clear evidence of the influence of gender norms on labor participation. Aims: In this paper we examine: (1) how gender norms affect women's access to FTE across 97 countries; (2) associations between FTE and women's self-reported health self-rated (SRH) across different normative contexts (i.e., countries where it is common vs. uncommon for women to stay home); and (3) how women's FTE and gender norms changed over time in four countries. Data: We used time-series data from the World Values Survey and European Values Survey conducted in over 100 countries between 1981 and 2014. Both surveys attempt to capture norms, beliefs and values in addition to sociodemographic information among a nationally representative adult population in each country. The sample for the cross-sectional analyses (aims 1 and 2) included 97 countries and 131,132 respondents. The sample for aim 3 included data from Argentina, Egypt, Finland and Japan. Variables: Our outcome of interest was pro-equality norms in the context of access to the labor market for women. Respondents were asked "if jobs are scarce, men should have more right to a job than women do?". Response options included no, neither or yes. We created a binary variable to represent pro-equality norms. We included employment status and SRH as exposures of interest. Analysis: We used individual-level data to generate on-average and sex-stratified estimates of the outcome and exposures for each country, at each time point. We estimated the percentage of all respondents, of women, and of men who held pro-equality norms (believe that men should not have more right to a job than women), the percentage who were employed full time, and the average level of SRH. To measure gender inequality in FTE, we also estimated the absolute difference in FTE between women and men for each country at each time point. First, we conducted descriptive, cross-sectional ecological analyses using one survey per country from wave 5 or 6 (whichever was most recent) to examine associations between pro-equality norms and employment status as a proxy for associations between norms and the context of employment in each country. We also examined associations between pro-equality norms and SRH. We then specified adjusted logistic regression models with controls for age, sex and education to examine associations between pro-equality norms and employment status. To examine if the relationship between FTE and SRH varied by normative context, we grouped countries in quartiles of pro-equality norms. Finally, we conducted descriptive ecological analyses of the relationship between pro-equality norms and employment status over time in four countries. Results: Objective 1: Gender norms intersect with socio-cultural contexts in determining women's FTE. While in some countries gender norms aligned positively with women's access to employment (i.e., more equal norms matched more equality in FTE), in Eastern Europe and South America we observed a mismatch. In Eastern Europe we found strong norms against equal access but small sex differences in FTE. In South America, we observed a stark difference in FTE favoring men, despite positive gender norms promoting women's paid employment. Objective 2: We found the association between SRH and FTE to vary across normative contexts. For instance, while in Scandinavian countries it was protective to be a woman in FTE and harmful not to work full-time, we found the opposite effect in Middle Eastern countries. Objective 3: We found a general tendency to move toward greater equality in norms and FTE over time everywhere in the world. However, political and economic events can generate variations over time and setbacks in progress toward equality.We specifically looked at 4 countries: Argentina, Egypt, Finland and Japan and assessed the effects of economic, political and national legislative changes on FTE over time. Implications: This paper contributes to the conversation on tensions between universal justice and contextual factors affecting one's health. To achieve purposeful and global universal health and justice, policy makers and global health practitioners must design effective, context-relevant interventions that are deeply and transparently informed by the values they embody. As we strive to achieve global gender equality, its meanings and purposes will vary across contexts in ways that demand people-led conversations and interventions.

The role of state breastfeeding laws and programs on exclusive breastfeeding practice among mothers in the special supplemental nutrition program for Women, Infants, and Children (WIC).

BACKGROUND: It is unclear if state laws supporting breastfeeding are associated with exclusive breastfeeding (EBF) practice among low-income mothers participating in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). The main objectives of our study were to assess the relationship between such laws and EBF among WIC-participating mothers and to assess whether this association varied by employment status. We also assessed how mother's exposure to WIC breastfeeding consultation was associated with EBF. METHODS: A cross-sectional study was conducted across seven WIC program locations (i.e., Georgia, Massachusetts, Nevada, Pennsylvania, Wisconsin, Wyoming, Chickasaw Nation) between July-August 2020. Data were collected using convenient sampling from each program location and surveys were administered electronically or on paper to WIC-participating mothers. We restricted our analysis to data from 1161 WIC-participating mothers with infants aged zero to five months old. Multivariable mixed models were used to estimate the relationship between our exposures of interest (i.e., number of laws supporting breastfeeding, employment-related breastfeeding laws, WIC breastfeeding consultation) and EBF, while controlling for potential confounders and accounting for clustering by program location. Effect modification by employment status was assessed on the additive and multiplicative scales. RESULTS: Among WIC-participating mothers living in program locations with no employment-related breastfeeding laws, EBF was 26% less prevalent for employed mothers compared to unemployed mothers (adjusted prevalence ratios [aPR]: 0.74, 95% CI: 0.67,0.83). Among all mothers, a one-unit increase in laws supporting breastfeeding was not associated with EBF (aPR: 0.88, 95% CI: 0.71,1.10). However, among employed mothers, living in areas with more employment-related laws was associated with a higher prevalence of EBF (aPR: 1.43, 95% CI: 0.83, 2.44). Infants whose mothers received a WIC breastfeeding consultation had 33% higher prevalence of being exclusively breastfed compared to infants whose mothers did not receive a WIC breastfeeding consultation (aPR: 1.33, 95% CI: 1.05,1.70). CONCLUSIONS: Infants whose WIC-participating mothers were employed, were less likely to be exclusively breastfed, but our effect modification analyses showed that laws supporting breastfeeding at the workplace may promote EBF among employed women. EBF was more prevalent among mothers who received a WIC breastfeeding consultation compared to those who did not receive such a consultation.

Integrating early stimulation and play at scale: study protocol for "MAHAY Mikolo", a multi-arm cluster-randomized controlled trial.

BACKGROUND: Hundreds of millions of children living in poverty worldwide are not reaching their full, developmental potential. Programs to promote nurturing and responsive caregiving, such as those in which community health workers (CHWs) conduct home visits to support optimal early childhood development (ECD), have been effective in small trials, but have not achieved similar success at scale. This study will explore two approaches to scale-up: converting a home-visiting model to a group-based model; and integrating the ECD curriculum into an existing government program. The objectives of the study are to: 1) Measure how the integration of ECD activities affects time and task allocation of CHWs and CHW psychosocial wellbeing; 2) Examine how the integration of ECD activities affects caregiver-child dyad participation in standard health and nutrition activities; and 3) Explore how the availability of age-appropriate play materials at home affects caregiver-child dyad participation rates in a group-based ECD program. METHODS: We will randomize 75 communities in rural Madagascar into three arms: 1) [C], which is the status quo (community-based health and nutrition program); 2) [T], which is C + ECD group sessions [T]; and 3) [T +], which is T with the addition of an enhanced play materials package for home use. All children between 6-30 months old at the time of the intervention launch will be eligible to participate in group activities. The intervention will last 12 months and is comprised of fortnightly group sessions in which the CHWs provide caregiver-child dyads with information relating to ECD; CHWs will also include structured time for caregivers to practice the play and child stimulation activities they have learned. We will administer monthly surveys to measure CHW time use and task allocation, and we will leverage administrative data to measure caregiver-child dyad participation in the group sessions. DISCUSSION: The results from the trial will provide the evidence base required to implement an integrated package of nutrition, health and ECD promotion activities at scale in Madagascar, and findings may be relevant in other low-income countries. TRIAL REGISTRATION: This trial is registered on the AEA Social Science Registry (AEARCTR-0004704) on November 15, 2019 and on ClinicalTrials.gov (NCT05129696) on November 22, 2021.