Neonatal mortality risk of vulnerable newborns by fine stratum of gestational age and birthweight for 230 679 live births in nine low- and middle-income countries, 2000-2017.

OBJECTIVE: To describe the mortality risks by fine strata of gestational age and birthweight among 230 679 live births in nine low- and middle-income countries (LMICs) from 2000 to 2017. DESIGN: Descriptive multi-country secondary data analysis. SETTING: Nine LMICs in sub-Saharan Africa, Southern and Eastern Asia, and Latin America. POPULATION: Liveborn infants from 15 population-based cohorts. METHODS: Subnational, population-based studies with high-quality birth outcome data were invited to join the Vulnerable Newborn Measurement Collaboration. All studies included birthweight, gestational age measured by ultrasound or last menstrual period, infant sex and neonatal survival. We defined adequate birthweight as 2500-3999 g (reference category), macrosomia as ≥4000 g, moderate low as 1500-2499 g and very low birthweight as <1500 g. We analysed fine strata classifications of preterm, term and post-term: ≥42+0 , 39+0 -41+6 (reference category), 37+0 -38+6 , 34+0 -36+6 ,34+0 -36+6 ,32+0 -33+6 , 30+0 -31+6 , 28+0 -29+6 and less than 28 weeks. MAIN OUTCOME MEASURES: Median and interquartile ranges by study for neonatal mortality rates (NMR) and relative risks (RR). We also performed meta-analysis for the relative mortality risks with 95% confidence intervals (CIs) by the fine categories, stratified by regional study setting (sub-Saharan Africa and Southern Asia) and study-level NMR (≤25 versus >25 neonatal deaths per 1000 live births). RESULTS: We found a dose-response relationship between lower gestational ages and birthweights with increasing neonatal mortality risks. The highest NMR and RR were among preterm babies born at <28 weeks (median NMR 359.2 per 1000 live births; RR 18.0, 95% CI 8.6-37.6) and very low birthweight (462.8 per 1000 live births; RR 43.4, 95% CI 29.5-63.9). We found no statistically significant neonatal mortality risk for macrosomia (RR 1.1, 95% CI 0.6-3.0) but a statistically significant risk for all preterm babies, post-term babies (RR 1.3, 95% CI 1.1-1.5) and babies born at 370 -386 weeks (RR 1.2, 95% CI 1.0-1.4). There were no statistically significant differences by region or underlying neonatal mortality. CONCLUSIONS: In addition to tracking vulnerable newborn types, monitoring finer categories of birthweight and gestational age will allow for better understanding of the predictors, interventions and health outcomes for vulnerable newborns. It is imperative that all newborns from live births and stillbirths have an accurate recorded weight and gestational age to track maternal and neonatal health and optimise prevention and care of vulnerable newborns.

Climate shocks and nutrition: The role of food security policies and programs in enhancing maternal and neonatal survival in Niger.

Niger is afflicted with high rates of poverty, high fertility rates, frequent environmental crises, and climate change. Recurrent droughts and floods have led to chronic food insecurity linked to poor maternal and neonatal nutrition outcomes in vulnerable regions. We analyzed maternal and neonatal nutrition trends and subnational variability between 2000 and 2021 with a focus on the implementation of policies and programs surrounding two acute climate shocks in 2005 and 2010. We used four sources of data: (a) national household surveys for maternal and newborn nutritional indicators allowing computation of trends and differences at national and regional levels; (b) document review of food security reports; (c) 30 key informant interviews and; (d) one focus group discussion. Many food security policies and nutrition programs were enacted from 2000 to 2020. Gains in maternal and neonatal nutrition indicators were more significant in targeted vulnerable regions of Maradi, Zinder, Tahoua and Tillabéri, from 2006 to 2021. However, poor access to financial resources for policy execution and suboptimal implementation of plans have hindered progress. In response to the chronic climate crisis over the last 20 years, the Nigerien government and program implementers have demonstrated their commitment to reducing food insecurity and enhancing resilience to climate shocks by adopting a deliberate multisectoral effort. However, there is more that can be achieved with a continued focus on vulnerable regions to build resilience, targeting high risk populations, and investing in infrastructure to improve health systems, food systems, agriculture systems, education systems, and social protection.

COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune rheumatic Diseases (COVIAAD): safety, immunogenicity and antibody persistence at 12 months following Moderna Spikevax primary series.

OBJECTIVE: To assess the safety, immunogenicity and cellular responses following the Moderna Spikevax primary series in rheumatic disease. METHODS: We conducted a 12-month, prospective, non-randomised, open-label, comparative trial of adults with either rheumatoid arthritis (RA, n=131) on stable treatment; systemic lupus erythematosus (SLE, n=23) on mycophenolate mofetil (MMF); other rheumatic diseases on prednisone ≥10 mg/day (n=8) or age-matched/sex-matched controls (healthy control, HC, n=58). Adverse events (AEs), humoral immune responses (immunogenicity: IgG positivity for anti-SARS-CoV-2 spike protein and its receptor binding domain, neutralising antibodies (NAbs)), cellular responses (ELISpot) and COVID-19 infection rates were assessed. RESULTS: Frequency of solicited self-reported AEs following vaccination was similar across groups (HC 90%, RA 86%, SLE 90%); among them, musculoskeletal AEs were more frequent in RA (HC 48% vs RA 66% (Δ95% CI CI 3 to 32.6)). Disease activity scores did not increase postvaccination. No vaccine-related serious AEs were reported. Postvaccination immunogenicity was reduced in RA and SLE (RA 90.2%, SLE 86.4%; for both, ΔCIs compared with HC excluded the null). Similarly, NAbs were reduced among patients (RA 82.6%, SLE 81.8%). In RA, age >65 (OR 0.3, 95% CI 0.1 to 0.8) and rituximab treatment (OR 0.003, 95% CI 0.001 to 0.02) were negative predictors of immunogenicity. ELISpot was positive in 16/52 tested RA and 17/26 HC (ΔCI 11.2-53.3). During the study, 11 HC, 19 RA and 3 SLE patients self-reported COVID-infection. CONCLUSION: In COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune Diseases, the Moderna Spikevax primary series was safe. MMF, RA age >65 and rituximab were associated with reduced vaccine-induced protection.

Neonatal mortality risk of large-for-gestational-age and macrosomic live births in 15 countries, including 115.6 million nationwide linked records, 2000-2020.

OBJECTIVE: We aimed to compare the prevalence and neonatal mortality associated with large for gestational age (LGA) and macrosomia among 115.6 million live births in 15 countries, between 2000 and 2020. DESIGN: Population-based, multi-country study. SETTING: National healthcare systems. POPULATION: Liveborn infants. METHODS: We used individual-level data identified for the Vulnerable Newborn Measurement Collaboration. We calculated the prevalence and relative risk (RR) of neonatal mortality among live births born at term + LGA (>90th centile, and also >95th and >97th centiles when the data were available) versus term + appropriate for gestational age (AGA, 10th-90th centiles) and macrosomic (≥4000, ≥4500 and ≥5000 g, regardless of gestational age) versus 2500-3999 g. INTERGROWTH 21st served as the reference population. MAIN OUTCOME MEASURES: Prevalence and neonatal mortality risks. RESULTS: Large for gestational age was common (median prevalence 18.2%; interquartile range, IQR, 13.5%-22.0%), and overall was associated with a lower neonatal mortality risk compared with AGA (RR 0.83, 95% CI 0.77-0.89). Around one in ten babies were ≥4000 g (median prevalence 9.6% (IQR 6.4%-13.3%), with 1.2% (IQR 0.7%-2.0%) ≥4500 g and with 0.2% (IQR 0.1%-0.2%) ≥5000 g). Overall, macrosomia of ≥4000 g was not associated with increased neonatal mortality risk (RR 0.80, 95% CI 0.69-0.94); however, a higher risk was observed for birthweights of ≥4500 g (RR 1.52, 95% CI 1.10-2.11) and ≥5000 g (RR 4.54, 95% CI 2.58-7.99), compared with birthweights of 2500-3999 g, with the highest risk observed in the first 7 days of life. CONCLUSIONS: In this population, birthweight of ≥4500 g was the most useful marker for early mortality risk in big babies and could be used to guide clinical management decisions.

Risk factors for neonatal mortality: an observational cohort study in Sarlahi district of rural southern Nepal.

OBJECTIVES: To assess the association between maternal characteristics, adverse birth outcomes (small-for-gestational-age (SGA) and/or preterm) and neonatal mortality in rural Nepal. DESIGN: This is a secondary observational analysis to identify risk factors for neonatal mortality, using data from a randomised trial to assess the impact of newborn massage with different oils on neonatal mortality in Sarlahi district, Nepal. SETTING: Rural Sarlahi district, Nepal. PARTICIPANTS: 40 119 pregnant women enrolled from 9 September 2010 to 16 January 2017. MAIN OUTCOME: The outcome variable is neonatal death. Cox regression was used to estimate adjusted Hazard Ratios (aHRs) to assess the association between adverse birth outcomes and neonatal mortality. RESULTS: There were 32 004 live births and 998 neonatal deaths. SGA and/or preterm birth was strongly associated with increased neonatal mortality: SGA and preterm (aHR: 7.09, 95% CI: (4.44 to 11.31)), SGA and term/post-term (aHR: 2.12, 95% CI: (1.58 to 2.86)), appropriate-for-gestational-age/large-for-gestational-age and preterm (aHR: 3.23, 95% CI: (2.30 to 4.54)). Neonatal mortality was increased with a history of prior child deaths (aHR: 1.53, 95% CI: (1.24 to 1.87)), being a twin or triplet (aHR: 5.64, 95% CI: (4.25 to 7.48)), births at health posts/clinics or in hospital (aHR: 1.34, 95% CI: (1.13 to 1.58)) and on the way to facilities or outdoors (aHR: 2.26, 95% CI: (1.57 to 3.26)). Risk was lower with increasing maternal height from <145 cm to 145-150 cm (aHR: 0.78, 95% CI: (0.65 to 0.94)) to ≥150 cm (aHR: 0.57, 95% CI: (0.47 to 0.68)), four or more antenatal care (ANC) visits (aHR: 0.67, 95% CI: (0.53 to 0.86)) and education >5 years (aHR: 0.75, 95% CI: (0.62 to 0.92)). CONCLUSION: SGA and/or preterm birth are strongly associated with increased neonatal mortality. To reduce neonatal mortality, interventions that prevent SGA and preterm births by promoting ANC and facility delivery, and care of high-risk infants after birth should be tested. TRIAL REGISTRATION NUMBER: NCT01177111.

Radiosensitizing oxygenation changes in murine tumors treated with VEGF-ablation therapy are measurable using oxygen enhanced-MRI (OE-MRI).

PURPOSE: There is a significant need for a widely available, translatable, sensitive and non-invasive imaging biomarker for tumor hypoxia in radiation oncology. Treatment-induced changes in tumor tissue oxygenation can alter the sensitivity of cancer tissues to radiation, but the relative difficulty in monitoring the tumor microenvironment results in scarce clinical and research data. Oxygen-Enhanced MRI (OE-MRI) uses inhaled oxygen as a contrast agent to measure tissue oxygenation. Here we investigate the utility of dOE-MRI, a previously validated imaging approach employing a cycling gas challenge and independent component analysis (ICA), to detect VEGF-ablation treatment-induced changes in tumor oxygenation that result in radiosensitization. METHODS: Murine squamous cell carcinoma (SCCVII) tumor-bearing mice were treated with 5 mg/kg anti-VEGF murine antibody B20 (B20-4.1.1, Genentech) 2-7 days prior to radiation treatment, tissue collection or MR imaging using a 7 T scanner. dOE-MRI scans were acquired for a total of three repeated cycles of air (2 min) and 100% oxygen (2 min) with responding voxels indicating tissue oxygenation. DCE-MRI scans were acquired using a high molecular weight (MW) contrast agent (Gd-DOTA based hyperbranched polygylcerol; HPG-GdF, 500 kDa) to obtain fractional plasma volume (fPV) and apparent permeability-surface area product (aPS) parameters derived from the MR concentration-time curves. Changes to the tumor microenvironment were evaluated histologically, with cryosections stained and imaged for hypoxia, DNA damage, vasculature and perfusion. Radiosensitizing effects of B20-mediated increases in oxygenation were evaluated by clonogenic survival assays and by staining for DNA damage marker γH2AX. RESULTS: Tumors from mice treated with B20 exhibit changes to their vasculature that are consistent with a vascular normalization response, and result in a temporary period of reduced hypoxia. DCE-MRI using injectable contrast agent HPG-GDF measured decreased vessel permeability in treated tumors, while dOE-MRI using inhaled oxygen as a contrast agent showed greater tissue oxygenation. These treatment-induced changes to the tumor microenvironment result in significantly increased radiation sensitivity, illustrating the utility of dOE-MRI as a non-invasive biomarker of treatment response and tumor sensitivity during cancer interventions. CONCLUSIONS: VEGF-ablation therapy-mediated changes to tumor vascular function measurable using DCE-MRI techniques may be monitored using the less invasive approach of dOE-MRI, an effective biomarker of tissue oxygenation that can monitor treatment response and predict radiation sensitivity.

Neonatal mortality risk of vulnerable newborns: A descriptive analysis of subnational, population-based birth cohorts for 238 203 live births in low- and middle-income settings from 2000 to 2017.

OBJECTIVE: We aimed to understand the mortality risks of vulnerable newborns (defined as preterm and/or born weighing smaller or larger compared to a standard population), in low- and middle-income countries (LMICs). DESIGN: Descriptive multi-country, secondary analysis of individual-level study data of babies born since 2000. SETTING: Sixteen subnational, population-based studies from nine LMICs in sub-Saharan Africa, Southern and Eastern Asia, and Latin America. POPULATION: Live birth neonates. METHODS: We categorically defined five vulnerable newborn types based on size (large- or appropriate- or small-for-gestational age [LGA, AGA, SGA]), and term (T) and preterm (PT): T + LGA, T + SGA, PT + LGA, PT + AGA, and PT + SGA, with T + AGA (reference). A 10-type definition included low birthweight (LBW) and non-LBW, and a four-type definition collapsed AGA/LGA into one category. We performed imputation for missing birthweights in 13 of the studies. MAIN OUTCOME MEASURES: Median and interquartile ranges by study for the prevalence, mortality rates and relative mortality risks for the four, six and ten type classification. RESULTS: There were 238 203 live births with known neonatal status. Four of the six types had higher mortality risk: T + SGA (median relative risk [RR] 2.6, interquartile range [IQR] 2.0-2.9), PT + LGA (median RR 7.3, IQR 2.3-10.4), PT + AGA (median RR 6.0, IQR 4.4-13.2) and PT + SGA (median RR 10.4, IQR 8.6-13.9). T + SGA, PT + LGA and PT + AGA babies who were LBW, had higher risk compared with non-LBW babies. CONCLUSIONS: Small and/or preterm babies in LIMCs have a considerably increased mortality risk compared with babies born at term and larger. This classification system may advance the understanding of the social determinants and biomedical risk factors along with improved treatment that is critical for newborn health.

Small babies, big risks: global estimates of prevalence and mortality for vulnerable newborns to accelerate change and improve counting.

Small newborns are vulnerable to mortality and lifelong loss of human capital. Measures of vulnerability previously focused on liveborn low-birthweight (LBW) babies, yet LBW reduction targets are off-track. There are two pathways to LBW, preterm birth and fetal growth restriction (FGR), with the FGR pathway resulting in the baby being small for gestational age (SGA). Data on LBW babies are available from 158 (81%) of 194 WHO member states and the occupied Palestinian territory, including east Jerusalem, with 113 (58%) having national administrative data, whereas data on preterm births are available from 103 (53%) of 195 countries and areas, with only 64 (33%) providing national administrative data. National administrative data on SGA are available for only eight countries. Global estimates for 2020 suggest 13·4 million livebirths were preterm, with rates over the past decade remaining static, and 23·4 million were SGA. In this Series paper, we estimated prevalence in 2020 for three mutually exclusive types of small vulnerable newborns (SVNs; preterm non-SGA, term SGA, and preterm SGA) using individual-level data (2010-20) from 23 national datasets (∼110 million livebirths) and 31 studies in 18 countries (∼0·4 million livebirths). We found 11·9 million (50% credible interval [Crl] 9·1-12·2 million; 8·8%, 50% Crl 6·8-9·0%) of global livebirths were preterm non-SGA, 21·9 million (50% Crl 20·1-25·5 million; 16·3%, 14·9-18·9%) were term SGA, and 1·5 million (50% Crl 1·2-4·2 million; 1·1%, 50% Crl 0·9-3·1%) were preterm SGA. Over half (55·3%) of the 2·4 million neonatal deaths worldwide in 2020 were attributed to one of the SVN types, of which 73·4% were preterm and the remainder were term SGA. Analyses from 12 of the 23 countries with national data (0·6 million stillbirths at ≥22 weeks gestation) showed around 74% of stillbirths were preterm, including 16·0% preterm SGA and approximately one-fifth of term stillbirths were SGA. There are an estimated 1·9 million stillbirths per year associated with similar vulnerability pathways; hence integrating stillbirths to burden assessments and relevant indicators is crucial. Data can be improved by counting, weighing, and assessing the gestational age of every newborn, whether liveborn or stillborn, and classifying small newborns by the three vulnerability types. The use of these more specific types could accelerate prevention and help target care for the most vulnerable babies.

How Does Job Insecurity and Workplace Activity Limitations Relate to Rheumatic Disease Symptom Trajectories in Young Adulthood? A Longitudinal Study.

OBJECTIVE: Workplace and labor market conditions are associated with the health of the working population. A longitudinal study was conducted among young adults with rheumatic disease to examine workplace activity limitations and job insecurity and their relationship with disease symptom trajectories. METHODS: Three online surveys were administered to young adults with rheumatic disease over 27 months. Self-reported data on pain, fatigue, and disease activity were collected. Workplace activity limitations and job insecurity were measured. Group-based discrete mixture models determined pain, fatigue, and disease activity trajectory groups. Robust Poisson regression models were fitted to examine the relationship among workplace activity limitations, job insecurity, and trajectory group membership. RESULTS: In total, 124 participants (mean ± SD age 29 ± 4.5 years) with rheumatic disease were recruited. At baseline, participants reported considerable workplace activity limitations (10.35 ± 5.8), and 36% of participants indicated experiencing job insecurity. We identified 2 latent rheumatic disease symptom trajectory groups. The first group had high persistent pain, fatigue, or disease activity; the second group had low persistent disease symptoms over time. Greater workplace activity limitations were associated with an increased relative risk (RR) of being in the high persistent severe pain (RR 1.02 [95% confidence interval (95% CI) 1.01, 1.03]), fatigue (RR 1.02 [95% CI 1.01, 1.03]), and disease activity trajectory groups (RR 1.02 [95% CI 1.01, 1.03]). Job insecurity was associated with an increased RR of membership in the high persistent pain (RR 1.14 [95% CI 1.04, 1.25]) and disease activity trajectory groups (RR 1.11 [95% CI 1.00, 1.22]). CONCLUSION: Workplace activity limitations and job insecurity represent working conditions that are associated with the health of young adults with rheumatic disease and should be examined as potential targets for intervention.

Prevalence and predictors of spontaneous preterm births in Nepal: findings from a prospective, population-based pregnancy cohort in rural Nepal-a secondary data analysis.

OBJECTIVE: Preterm birth can have short-term and long-term complications for a child. Socioeconomic factors and pregnancy-related morbidities may be important to predict and prevent preterm births in low-resource settings. The objective of our study was to find prevalence and predictors of spontaneous preterm birth in rural Nepal. DESIGN: This is a secondary observational analysis of trial data (registration number NCT01177111). SETTING: Rural Sarlahi district, Nepal. PARTICIPANTS: 40 119 pregnant women enrolled from 9 September 2010 to 16 January 2017. OUTCOME MEASURES: The outcome variable is spontaneous preterm birth. Generalized Estimating Equations Poisson regression with robust variance was fitted to present effect estimates as risk ratios. RESULT: The prevalence of spontaneous preterm birth was 14.5% (0.5% non-spontaneous). Characteristics not varying in pregnancy associated with increased risk of preterm birth were maternal age less than 18 years (adjusted risk ratio=1.13, 95% CI: 1.02 to 1.26); being Muslim (1.53, 1.16 to 2.01); first pregnancy (1.15, 1.04 to 1.28); multiple births (4.91, 4.20 to 5.75) and male child (1.10, 1.02 to 1.17). Those associated with decreased risk were maternal education >5 years (0.81, 0.73 to 0.90); maternal height ≥150 cm (0.89, 0.81 to 0.98) and being from wealthier families (0.83, 0.74 to 0.93). Pregnancy-related morbidities associated with increased risk of preterm birth were vaginal bleeding (1.53, 1.08 to 2.18); swelling (1.37, 1.17 to 1.60); high systolic blood pressure (BP) (1.47, 1.08 to 2.01) and high diastolic BP (1.41, 1.17 to 1.70) in the third trimester. Those associated with decreased risk were respiratory problem in the third trimester (0.86, 0.79 to 0.94); having poor appetite, nausea and vomiting in the second trimester (0.86, 0.80 to 0.92) and third trimester (0.86, 0.79 to 0.94); and higher weight gain from second to third trimester (0.89, 0.87 to 0.90). CONCLUSION: The prevalence of preterm birth is high in rural Nepal. Interventions that increase maternal education may play a role. Monitoring morbidities during antenatal care to intervene to reduce them through an effective health system may help reduce preterm birth.

Psychosocial Assessment Tools for Youth with Type 1 Diabetes: a 10-Year Review.

PURPOSE OF REVIEW: There is a notable lack of consistency in the measurement of psychosocial factors affecting youth with type 1 diabetes, resulting in a need for increased measurement standardization and establishment of measures tailored to capture unique experiences faced by youth. This review sought to assess 10 years of extant literature (2011 to 2020) to identify which established measurement tools are commonly used and to evaluate new measurement tools that were introduced during this period. RECENT FINDINGS: There are a variety of psychosocial factors affecting youth, and assessment of these measures has shown substantial variability. Our review found that most frequently cited scales were those pertaining to self-efficacy, diabetes distress, family conflict, autonomy, and fear of hypoglycemia. During our review period, experts developed and validated 21 new scales, the majority of which sought to evaluate areas pertaining to diabetes distress. Of the common scales and newly developed scales identified in this review, psychometric properties showcase high reliability and validity, and items are becoming increasingly specific to youth but still lack assessment of how youth perceive technology's impact on diabetes management. The field would benefit from measures employing more nuanced age specificity and addressing technology usage.

Measuring Quality of Maternal, Neonatal, Child, Reproductive Health and Nutrition Care with tools developed by the RADAR project and tested in Sub Saharan Africa.

Increasing coverage of evidence-based maternal, neonatal, child, reproductive health and nutrition (MNCRHN) programs in low- and middle-income countries has coincided with dramatic improvements in health despite variable quality of implementation. Comprehensive evaluation to inform program improvement requires standardized but adaptable tools, which the Real Accountability, Data Analysis for Results (RADAR) project has developed. To inform selection of tools and methods packages ('packages') to measure program quality of care (QoC), we documented experiences testing the packages, which were developed and adapted based on global and local expertise, and pre- and pilot-testing. We conducted cross-sectional studies in 2018-2019 on the quality of 1) integrated community case management, 2) counseling on maternal, infant, and young child feeding, 3) intrapartum care, and 4) family planning counseling in Mali, Mozambique, Tanzania, and Malawi. Herein we describe package performance and highlight experiences that inform their selection and use. Direct observation packages provided high-quality, immediately applicable results but they required specialized expertise, in-person collection, adequate patient volume, reasonable wait times, and unambiguously 'correct' provision of care. General satisfaction questions from exit interview packages produced unvaryingly positive responses despite variable observed quality of care. Variation increased when questions were more targeted, but findings on caregiver and client's recall of recommendations were more actionable. When interactive, clinical vignettes can capture knowledge of clinical care. But for conditions that can be simulated, like provision of family planning counseling, we could capture provider practice from simulated clients. Clinicians could more easily demonstrate tactile aspects of intrapartum care using observed structured clinical examinations, but this method required storage and transport of the required mannequins. Based on our findings we recommend ten questions upon which evaluators can base package selection. Findings from these packages inform programs and, in the context of comprehensive program evaluation enable us to link programs with impact.

Demographic, socio-economic, obstetric, and behavioral factors associated with small-and large-for-gestational-age from a prospective, population-based pregnancy cohort in rural Nepal: a secondary data analysis.

BACKGROUND: In South Asia, a third of babies are born small-for-gestational age (SGA). The risk factors are well described in the literature, but many studies are in high-and-middle income countries or measure SGA on facility births only. There are fewer studies that describe the prevalence of risk factors for large-for-gestational age (LGA) in low-income countries. We aim to describe the factors associated with SGA and LGA in a population-based cohort of pregnant women in rural Nepal. METHODS: This is a secondary data analysis of community-based trial on neonatal oil massage (22,545 women contributing 39,479 pregnancies). Demographic, socio-economic status (SES), medical/obstetric history, and timing of last menstruation were collected at enrollment. Vital signs, illness symptoms, and antenatal care (ANC) attendance were collected throughout the pregnancy and neonatal weight was measured for live births. We conducted multivariate analysis using multinomial, multilevel logistic regression, reporting the odds ratio (OR) with 95% confidence intervals (CIs). Outcomes were SGA, LGA compared to appropriate-for-gestational age (AGA) and were multiply imputed using birthweight recalibrated to time at delivery. RESULTS: SGA was associated with nulligravida (OR: 2.12 95% CI: 1.93-2.34), gravida/nulliparous (OR: 1.86, 95% CI: 1.26-2.74), interpregnancy intervals less than 18 months (OR: 1.16, 95% CI: 1.07-1.27), and poor appetite/vomiting in the second trimester, (OR: 1.27, 95% CI: 1.19-1.35). Greater wealth (OR: 0.78, 95% CI: 0.69-0.88), swelling of hands/face in the third trimester (OR: 0.81, 95% CI: 0.69-0.94) parity greater than five (OR: 0.77, 95% CI: 0.65-0.92), male fetal sex (OR: 0.91, 95% CI: 0.86-0.98), and increased weight gain (OR: 0.93 per weight kilogram difference between 2nd and 3rd trimester, 95% CI: 0.92-0.95) were protective for SGA. Four or more ANC visits (OR: 0.53, 95% CI: 0.41-0.68) and respiratory symptoms in the third trimester (OR: 0.67, 95% CI: 0.54-0.84) were negatively associated with LGA, and maternal age < 18 years (OR: 1.39, 95% CI: 1.03-1.87) and respiratory symptoms in the second trimester (OR: 1.27, 95% CI: 1.07-1.51) were positively associated with LGA. CONCLUSIONS: Our findings are in line with known risk factors for SGA. Because the prevalence and mortality risk of LGA babies is low in this population, it is likely LGA status does not indicate underlaying illness. Improved and equitable access to high quality antenatal care, monitoring for appropriate gestational weight gain and increased monitoring of women with high-risk pregnancies may reduce prevalence and improve outcomes of SGA babies. TRIAL REGISTRATION: The study used in this secondary data analysis was registered at Clinicaltrials.gov NCT01177111.

Development of an imputation model to recalibrate birth weights measured in the early neonatal period to time at delivery and assessment of its impact on size-for-gestational age and low birthweight prevalence estimates: a secondary analysis of a pregnancy cohort in rural Nepal.

OBJECTIVES: In low-income countries, birth weights for home deliveries are often measured at the nadir when babies may lose up of 10% of their birth weight, biasing estimates of small-for-gestational age (SGA) and low birth weight (LBW). We aimed to develop an imputation model that predicts the 'true' birth weight at time of delivery. DESIGN: We developed and applied a model that recalibrates weights measured in the early neonatal period to time=0 at delivery and uses those recalibrated birth weights to impute missing birth weights. SETTING: This is a secondary analysis of pregnancy cohort data from two studies in Sarlahi district, Nepal. PARTICIPANTS: The participants are 457 babies with daily weights measured in the first 10 days of life from a subsample of a larger clinical trial on chlorhexidine (CHX) neonatal skin cleansing and 31 116 babies followed through the neonatal period to test the impact of neonatal massage oil type (Nepal Oil Massage Study (NOMS)). OUTCOME MEASURES: We developed an empirical Bayes model of early neonatal weight change using CHX trial longitudinal data and applied it to the NOMS dataset to recalibrate and then impute birth weight at delivery. The outcomes are size-for-gestational age and LBW. RESULTS: When using the imputed birth weights, the proportion of SGA is reduced from 49% (95% CI: 48% to 49%) to 44% (95% CI: 43% to 44%). Low birth weight is reduced from 30% (95% CI: 30% to 31%) to 27% (95% CI: 26% to 27%). The proportion of babies born large-for-gestational age increased from 4% (95% CI: 4% to 4%) to 5% (95% CI: 5% to 5%). CONCLUSIONS: Using weights measured around the nadir overestimates the prevalence of SGA and LBW. Studies in low-income settings with high levels of home births should consider a similar recalibration and imputation model to generate more accurate population estimates of small and vulnerable newborns.

Training Physicians in Motivational Communication to Address Influenza Vaccine Hesitation: A Proof-of-Concept Study.

BACKGROUND: Strategies to support health care professionals on how to address vaccine hesitancy are needed. METHODS: We developed a 4-h Motivational Communication (MC) training program tailored to help physicians address hesitancy related to influenza vaccination among patients living with rheumatoid arthritis. Five MC competencies were evaluated at baseline and post-training with a standardized patient using the Motivational Interviewing Treatment Integrity [MITI] scale. Adherence to MC during clinical consultations and changes in vaccine intentions was measured as secondary outcomes. RESULTS: Seven rheumatology physicians participated in the training. MITI scores increased in all participants, and 71% (n = 5) achieved thresholds of clinical competency (i.e., ≥3.5/5 at MITI global score and ≥3/5 on at least 3 individual competency score) post-training. Autonomy/support and empathy competencies reached competency thresholds (+2.4 ± 1.3 to +4.1 ± 0.7 and +2.1 ± 0.7 to +4.1 ± 0.7, respectively). Evocation and collaboration competencies improved but without reaching competency thresholds (+1.4 ± 0.8 to +3.1 ± 1.1; +1.4 ± 0.8 to +2.9 ± 1.1, respectively). Direction did not improve. Among 21 patient consultations post-training, 15 (71%) were MC-consistent. Of the 15 patients, 67% (10/15) intended to receive the influenza vaccine and 33% (5/15) received it. CONCLUSION: A brief MC training program targeting vaccine hesitancy increased MC competency among rheumatology physicians and promoted behavioral change among patients.

Influenza Vaccine Hesitancy and Its Determinants Among Rheumatology Patients.

OBJECTIVE: Patients with rheumatic disease (RD) have an increased risk of influenza and its complications. Despite inactivated influenza vaccine (IIV) recommendations, IIV uptake in patients with RD is suboptimal, a problem of increasing importance in the COVID-19 era. We estimated the frequency of IIV hesitancy and associated factors among Canadian patients with RD. METHODS: A cross-sectional vaccine hesitancy survey was completed by rheumatology clinic patients (November 2019 to January 2020). Patients rated their likelihood of receiving the influenza vaccine (scale of 0-10). We categorized these as follows: likely to refuse (scale of 0-2), uncertain (scale of 3-7), or likely to accept (scale of 8-10). Multivariate logistical regression was used to evaluate factors associated with vaccine hesitancy. RESULTS: A total of 282 patients (63.5% of those approached) completed the survey, with 165 (58.5%) being likely to accept, 67 (23.8%) being likely to refuse, and 50 (17.7%) uncertain. Uncertain patients were younger and more likely to be employed than those in the other two groups. No previous influenza vaccination (odds ratio [OR] 36.6, 95% confidence interval [CI] 5.3-252.9), belief that vaccination should not be mandatory (OR 0.1, 95% CI 0.0-0.7), unwillingness to take time off work to be vaccinated (OR 6.8, 95% CI 1.5-30.6), and distrust in pharmaceutical companies (OR 41.0, 95% CI 5.6-301.5) predicted likeliness to refuse. Reluctance to pay for vaccination (OR 2.8, 95% CI 1.1-7.5) and no previous influenza vaccination (OR 18.9, 95% CI 3.3-109.7) predicted uncertainty. CONCLUSION: More than 40% of rheumatology patients are either likely to refuse or uncertain about receiving IIV. This contributes to suboptimal vaccine coverage in this population. Interventions addressing these concerns are needed, particularly in the COVID-19 era.

Inter-segmental coordination amplitude and variability differences during gait in patients with Ehlers-Danlos syndrome and healthy adults.

BACKGROUND: There is limited research examining gait and inter-segmental coordination in patients with Ehlers-Danlos syndrome. The objective was to compare lower extremity inter-segmental coordination amplitude and variability during gait between patients with Ehlers-Danlos syndrome and healthy adults. METHODS: This cross-sectional study included participants with Ehlers-Danlos syndrome (n = 13) and healthy adults (n = 14). Gait data were acquired using a motion capture system and force plates. Participants ambulated at self-selected speeds for five trials. Inter-segmental coordination was quantified using continuous relative phase, which examined the dynamic interaction between the thigh-shank and shank-foot paired segments (i.e. phase space relation). A 2-way mixed analysis of variance examined the effects of groups (Ehlers-Danlos and healthy) and gait phases (stance and swing phase) on inter-segmental coordination amplitude and between-trial variability. Effect sizes were calculated using Cohen's d. FINDINGS: The Ehlers-Danlos group had greater inter-segmental coordination variability compared to the healthy group for foot-shank and shank-thigh segment pairs in the sagittal plane over stance and swing phases (P = 0.04; small to large effect sizes). The Ehlers-Danlos group also had greater variability in the frontal plane at the foot-shank segment pair during stance phase (P = 0.03; large effect). There were no differences in inter-segmental coordination amplitude between groups (P = 0.06 to 0.85). INTERPRETATION: Patients with Ehlers-Danlos syndrome have more variability between gait trials in lower limb motor coordination than healthy adults. This may be related to the impaired proprioception, reduced strength, pain, or slower gait speed seen in this population.

Rheumatic Disease Disclosure at the Early Career Phase and Its Impact on the Relationship Between Workplace Supports and Presenteeism.

OBJECTIVE: Young adults with rheumatic disease face challenges communicating health needs, accessing workplace support, and sustaining productivity. Our objective was to examine whether disclosure modifies the relationship between workplace support and presenteeism. METHODS: An online survey was administered to Canadian young adults with rheumatic disease and asked about presenteeism (0 = health had no effect on work; 10 = health completely prevented working), workplace support need, availability, and use and whether health details were disclosed to an immediate supervisor. A multivariable robust linear regression model was conducted and stratified by those who did and did not disclose the details of their health to their supervisor. RESULTS: A total of 306 participants completed the survey with a mean ± SD presenteeism score of 4.89 ± 2.65. More than 70% disclosed health details to their supervisor; those who disclosed reported greater presenteeism (mean ± SD 5.2 ± 2.5) when compared to those who did not disclose (mean ± SD 4.2 ± 2.61). Greater disease severity was associated with disclosure. Half of the participants reported unmet workplace support needs (53%), 32% reported that their workplace support needs were met, and 15% reported exceeded workplace support needs. The relationship between presenteeism and workplace support needs was modified by disclosure. For participants who disclosed, workplace support needs that were unmet (ß = 1.59 [95% confidence interval (95% CI) 0.75, 2.43]) and that were met (ß = 1.25 [95% CI 0.39, 2.11]) were associated with greater presenteeism when compared to those with exceeded workplace support needs. CONCLUSION: To address presenteeism, strategies should be developed for young adults with rheumatic disease to foster access to available workplace supports and to navigate disclosure decisions.

Assessing provider performance of intrapartum care using simulated encounters and clinical vignettes: A comparison study from Tanzania.

OBJECTIVE: To compare clinical vignettes and objective structured clinical examinations (OSCE) as methods for assessing the quality of intrapartum care among skilled providers in rural primary-level health facilities in Tanzania. METHODS: Cross-sectional study conducted at six health facilities in the Simiyu region of Tanzania. Providers were assessed using OSCE and clinical vignettes in spontaneous delivery, neonatal resuscitation, and management of postpartum hemorrhage. Trained researchers used a structured clinical checklist. The frequencies of items are presented as percentages and the agreement of the methods of assessment are reported using kappa statistics (high: kappa > 0.80, moderate: kappa = 0.60-0.80, low: kappa < 0.60). RESULTS: Most healthcare providers were female (60.7%), registered nurses by training (29.0%), and worked in a dispensary (56.1%), with an average age of 33 years and an average of 7.4 years of experience in their respective professions. Five items had high agreement between OSCE and clinical vignettes: postpartum vital signs every 15 min, oxytocin within 1 min of birth, diagnosis of postpartum hemorrhage, elevating legs of the mother, and deciding on manual compression of the uterus. CONCLUSION: OSCE and clinical vignettes should be viewed as complimentary to one another in the assessment of provider knowledge and skill, with priority given to OSCE, particularly in intrapartum care.

Comparability of family planning quality of care measurement tools in low-and-middle income country settings: a systematic review.

BACKGROUND: In low-and-middle income countries (LMICs), accurate measures of the elements of quality care provided by a health worker through family planning services (also known as process quality) are required to ensure family's contraceptives needs are being met. There are many tools used to assess family planning process quality of care (QoC) but no one standardized method. Those measuring QoC in LMICs should select an appropriate tool based the program context and financial/logistical parameters, but they require data on how well each tool measures routine clinical care. We aim to synthesize the literature on validity/comparability of family planning process QoC measurement tools through a quantitative systematic review with no meta-analysis. METHODS: We searched six literature databases for studies that compared quality measurements from different tools using quantitative statistics such as sensitivity/specificity, kappa statistic or absolute difference. We extracted the comparative measure along with other relevant study information, organized by quality indicator domain (e.g. counseling and privacy), and then classified the measure by low, medium, and high agreement. RESULTS: We screened 8172 articles and identified eight for analysis. Studies comparing quality measurements from simulated clients, direct observation, client exit interview, provider knowledge quizzes, and medical record review were included. These eight studies were heterogenous in their methods and the measurements compared. There was insufficient data to estimate overall summary measures of validity for the tools. Client exit interviews compared to direct observation or simulated client protocols had the most data and they were a poor proxy of the actual quality care received for many measurements. CONCLUSION: To measure QoC consistently and accurately in LMICs, standardized tools and measures are needed along with an established method of combining them for a comprehensive picture of quality care. Data on how different tools proxy quality client care will inform these guidelines. Despite the small number of studies found during the review, we described important differences on how tools measure quality of care.

Accurate measures of process quality of care­or how well clinicians deliver services according to standards of care­are important to monitor, evaluate and improve service quality. Periodic surveys of health facilities or provider are the main source of national or regional quality of care data in many low- and middle-income countries. Many tools are used for these surveys: exit interviews with patients, observations of the visits by a clinician-assessor, simulated or mystery patients, and others. Implementers must select the appropriate and feasible tools for their program, context and setting but there is little information on how well different tools measure the same quality of care indicators.This review summarizes the current literature on the validity of measurements from different family planning quality of care tools. We found only eight studies, but we were able to see some differences important to consider when selecting the most appropriate tool. For instance, patients reported different events through an exit interview than what was documented by the assessor during the same visit. Exit interviews may be more appropriate to measure client experience or satisfaction rather than specifics of the care received. Knowing these differences will help implementers choose an appropriate tool depending on the focus of the quality assessment. This review contributes to the body of knowledge on improving quality of care measurements, resulting in better data to improve family planning services for patients.