DO IT Trial: vitamin D Outcomes and Interventions in Toddlers - a TARGet Kids! randomized controlled trial.

BackgroundVitamin D levels are alarmingly low (<75 nmol/L) in 65-70% of North American children older than 1 year. An increased risk of viral upper respiratory tract infections (URTI), asthma-related hospitalizations and use of anti-inflammatory medication have all been linked with low vitamin D. No study has determined whether wintertime vitamin D supplementation can reduce the risk of URTI and asthma exacerbations, two of the most common and costly illnesses of early childhood. The objectives of this study are: 1) to compare the effect of 'high dose' (2000 IU/day) vs. 'standard dose' (400 IU/day) vitamin D supplementation in achieving reductions in laboratory confirmed URTI and asthma exacerbations during the winter in preschool-aged Canadian children; and 2) to assess the effect of 'high dose' vitamin D supplementation on vitamin D serum levels and specific viruses that cause URTI.Methods/designThis study is a pragmatic randomized controlled trial. Over 4 successive winters we will recruit 750 healthy children 1-5 years of age. Participating physicians are part of a primary healthcare research network called TARGet Kids!. Children will be randomized to the 'standard dose' or 'high dose' oral supplemental vitamin D for a minimum of 4 months (200 children per group). Parents will obtain a nasal swab from their child with each URTI, report the number of asthma exacerbations and complete symptom checklists. Unscheduled physician visits for URTIs and asthma exacerbations will be recorded. By May, a blood sample will be drawn to determine vitamin D serum levels. The primary analysis will be a comparison of URTI rate between study groups using a Poisson regression model. Secondary analyses will compare vitamin D serum levels, asthma exacerbations and the frequency of specific viral agents between groups.DiscussionIdentifying whether vitamin D supplementation of preschoolers can reduce wintertime viral URTIs and asthma exacerbations and what dose is optimal may reduce population wide morbidity and associated health care and societal costs. This information will assist in determining practice and health policy recommendations related to vitamin D supplementation in healthy Canadian preschoolers

Parents\u27 perception of stroller use in young children: A qualitative study

Background: Despite their wide usage, it has recently been suggested that stroller use may reduce physical activity levels of young children. However, there have been no studies on stroller use as it relates to physical activity outcomes. The objectives of this study were to understand the context of stroller use for young children and parents\u27 perceptions of the relationship between stroller use and their children\u27s physical activity. Methods: Parents of children 1 to 5 years of age were recruited through two sites of TARGet Kids!, a primary-care, practice-based research network in Toronto, Canada. Fourteen semi-structured interviews were conducted. Interviews were audio recorded and transcribed verbatim and two independent reviewers conducted thematic analysis. A number of strategies were employed to ensure the trustworthiness of the data. Results: Parents discussed reasons for stroller use (i.e., transportation; storage; leisure; supervision/confinement; parent physical activity; and sleep), factors that influence the decision to use a stroller (i.e., caregiver choice; convenience, timing, distance; family lifestyle; and child preference), and perceived impact of stroller use on physical activity (i.e., most parents did not recognize a connection between stroller use and physical activity). Conclusion: This study provides a context for researchers and policy makers to consider when developing stroller related physical activity guidelines for young children

Screen Use and Mental Health Symptoms in Canadian Children and Youth during the COVID-19 Pandemic

Importance: Longitudinal research on specific forms of electronic screen use and mental health symptoms in children and youth during COVID-19 is minimal. Understanding the association may help develop policies and interventions targeting specific screen activities to promote healthful screen use and mental health in children and youth. Objective: To determine whether specific forms of screen use (television [TV] or digital media, video games, electronic learning, and video-chatting time) were associated with symptoms of depression, anxiety, conduct problems, irritability, hyperactivity, and inattention in children and youth during COVID-19. Design, Setting, and Participants: A longitudinal cohort study with repeated measures of exposures and outcomes was conducted in children and youth aged 2 to 18 years in Ontario, Canada, between May 2020 and April 2021 across 4 cohorts of children or youth: 2 community cohorts and 2 clinically referred cohorts. Parents were asked to complete repeated questionnaires about their children\u27s health behaviors and mental health symptoms during COVID-19. Main Outcomes and Measures: The exposure variables were children\u27s daily TV or digital media time, video game time, electronic-learning time, and video-chatting time. The mental health outcomes were parent-reported symptoms of child depression, anxiety, conduct problems and irritability, and hyperactivity/inattention using validated standardized tools. Results: This study included 2026 children with 6648 observations. In younger children (mean [SD] age, 5.9 [2.5] years; 275 male participants [51.7%]), higher TV or digital media time was associated with higher levels of conduct problems (age 2-4 years: β, 0.22 [95% CI, 0.10-0.35]; P \u3c.001; age ≥4 years: β, 0.07 [95% CI, 0.02-0.11]; P =.007) and hyperactivity/inattention (β, 0.07 [95% CI, 0.006-0.14]; P =.04). In older children and youth (mean [SD] age, 11.3 [3.3] years; 844 male participants [56.5%]), higher levels of TV or digital media time were associated with higher levels of depression, anxiety, and inattention; higher levels of video game time were associated with higher levels of depression, irritability, inattention, and hyperactivity. Higher levels of electronic learning time were associated with higher levels of depression and anxiety. Conclusions and Relevance: In this cohort study, higher levels of screen use were associated poor mental health of children and youth during the COVID-19 pandemic. These findings suggest that policy intervention as well as evidence-informed social supports are needed to promote healthful screen use and mental health in children and youth during the pandemic and beyond

New approaches and technical considerations in detecting outlier measurements and trajectories in longitudinal children growth data

Background Growth studies rely on longitudinal measurements, typically represented as trajectories. However, anthropometry is prone to errors that can generate outliers. While various methods are available for detecting outlier measurements, a gold standard has yet to be identified, and there is no established method for outlying trajectories. Thus, outlier types and their effects on growth pattern detection still need to be investigated. This work aimed to assess the performance of six methods at detecting different types of outliers, propose two novel methods for outlier trajectory detection and evaluate how outliers affect growth pattern detection. Methods We included 393 healthy infants from The Applied Research Group for Kids (TARGet Kids!) cohort and 1651 children with severe malnutrition from the co-trimoxazole prophylaxis clinical trial. We injected outliers of three types and six intensities and applied four outlier detection methods for measurements (model-based and World Health Organization cut-offs-based) and two for trajectories. We also assessed growth pattern detection before and after outlier injection using time series clustering and latent class mixed models. Error type, intensity, and population affected method performance. Results Model-based outlier detection methods performed best for measurements with precision between 5.72-99.89%, especially for low and moderate error intensities. The clustering-based outlier trajectory method had high precision of 14.93-99.12%. Combining methods improved the detection rate to 21.82% in outlier measurements. Finally, when comparing growth groups with and without outliers, the outliers were shown to alter group membership by 57.9 -79.04%. Conclusions World Health Organization cut-off-based techniques were shown to perform well in few very particular cases (extreme errors of high intensity), while model-based techniques performed well, especially for moderate errors of low intensity. Clustering-based outlier trajectory detection performed exceptionally well across all types and intensities of errors, indicating a potential strategic change in how outliers in growth data are viewed. Finally, the importance of detecting outliers was shown, given its impact on children growth studies, as demonstrated by comparing results of growth group detection

Randomised trials conducted using cohorts : a scoping review

Acknowledgements We thank Margaret Sampson, MLIS, PhD, AHIP (Children’s Hospital of Eastern Ontario, Ottawa, Canada) for developing the search strategies on behalf of the CONSORT team. We thank Dr Philippa Fibert, St Mary’s University, Twickenham, London for her help in screening publications for inclusion.Peer reviewe

Randomised trials conducted using cohorts: a scoping review

Introduction Cohort studies generate and collect longitudinal data for a variety of research purposes. Randomised controlled trials (RCTs) increasingly use cohort studies as data infrastructures to help identify and recruit trial participants and assess outcomes. Objective To examine the extent, range and nature of research using cohorts for RCTs and describe the varied definitions and conceptual boundaries for RCTs using cohorts. Design Scoping review. Data sources Searches were undertaken in January 2021 in MEDLINE (Ovid) and EBM Reviews-Cochrane Methodology Registry (Final issue, third Quarter 2012). Eligibility criteria Reports published between January 2007 and December 2021 of (a) cohorts used or planned to be used, to conduct RCTs, or (b) RCTs which use cohorts to recruit participants and/or collect trial outcomes, or (c) methodological studies discussing the use of cohorts for RCTs. Data extraction and synthesis Data were extracted on the condition being studied, age group, setting, country/ continent, intervention(s) and comparators planned or received, unit of randomisation, timing of randomisation, approach to informed consent, study design and terminology. Results A total of 175 full-text articles were assessed for eligibility. We identified 61 protocols, 9 descriptions of stand-alone cohorts intended to be used for future RCTs, 39 RCTs using cohorts and 34 methodological papers. The use and scope of this approach is growing. The thematics of study are far-ranging, including population health, oncology, mental and behavioural disorders, and musculoskeletal conditions. Authors reported that this approach can lead to more efficient recruitment, more representative samples, and lessen disappointment bias and crossovers. Conclusion This review outlines the development of cohorts to conduct RCTs including the range of use and innovative changes and adaptations. Inconsistencies in the use of terminology and concepts are highlighted. Guidance now needs to be developed to support the design and reporting of RCTs conducted using cohorts

Risk of adverse outcomes among infants of immigrant women according to birth-weight curves tailored to maternal world region of origin

Background: Infants of immigrant women in Western nations generally have lower birth weights than infants of native-born women. Whether this difference is physiologic or pathological is unclear. We determined whether the use of birth-weight curves tailored to maternal world region of origin would discriminate adverse neonatal and obstetric outcomes more accurately than a single birth-weight curve based on infants of Canadian-born women. Methods: We performed a retrospective cohort study of in-hospital singleton live births (328 387 to immigrant women, 761 260 to nonimmigrant women) in Ontario between 2002 and 2012 using population health services data linked to the national immigration database. We classified infants as small for gestational age (\u3c 10th percentile) or large for gestational age (≥ 90th percentile) using both Canadian and world region-specific birthweight curves and compared associations with adverse neonatal and obstetric outcomes. Results: Compared with world region-specific birth-weight curves, the Canadian curve classified 20 431 (6.2%) additional newborns of immigrant women as small for gestational age, of whom 15 467 (75.7%) were of East or South Asian descent. The odds of neonatal death were lower among small-for-gestational-age infants of immigrant women than among those of nonimmigrant women based on the Canadian birth-weight curve (adjusted odds ratio [OR] 0.83, 95% confidence interval [CI] 0.72-0.95), but higher when small for gestational age was defined by the world region- specific curves (adjusted OR 1.24, 95% CI 1.08- 1.42). Conversely, the odds of some adverse outcomes were lower among large-forgestational- age infants of immigrant women than among those of nonimmigrant women based on world region-specific birth-weight curves, but were similar based on the Canadian curve. Interpretation: World region-specific birthweight curves seemed to be more appropriate than a single Canadian population-based curve for assessing the risk of adverse neonatal and obstetric outcomes among small- and large-for-gestational-age infants born to immigrant women, especially those from the East and South Asian regions

Establishing a protocol for building a pan-Canadian population-based monitoring system for early childhood development for children with health disorders: Canadian Children's Health in Context Study (CCHICS)

Introduction Health disorders early in life have tremendous impact on children's developmental trajectories. Almost 80% of children with health disorders lack the developmental skills to take full advantage of school-based education relative to 27% of children without a health disorder. In Canada, there is currently a dearth of nationally representative data on the social determinants of early childhood development for children with health disorders. Evidence from Canada and other countries indicate t

Obstetric Outcomes in Women with Rheumatic Disease and COVID-19 in the Context of Vaccination Status

OBJECTIVE: To describe obstetric outcomes based on COVID-19 vaccination status, in women with rheumatic and musculoskeletal diseases (RMDs) who developed COVID-19 during pregnancy. METHODS: Data regarding pregnant women entered into the COVID-19 Global Rheumatology Alliance registry from 24 March 2020-25 February 2022 were analysed. Obstetric outcomes were stratified by number of COVID-19 vaccine doses received prior to COVID-19 infection in pregnancy. Descriptive differences between groups were tested using the chi -square or Fisher's exact test. RESULTS: There were 73 pregnancies in 73 women with RMD and COVID-19. Overall, 24.7% (18) of pregnancies were ongoing, while of the 55 completed pregnancies 90.9% (50) of pregnancies resulted in livebirths. At the time of COVID-19 diagnosis, 60.3% (n = 44) of women were unvaccinated, 4.1% (n = 3) had received one vaccine dose while 35.6% (n = 26) had two or more doses. Although 83.6% (n = 61) of women required no treatment for COVID-19, 20.5% (n = 15) required hospital admission. COVID-19 resulted in delivery in 6.8% (n = 3) of unvaccinated women and 3.8% (n = 1) of fully vaccinated women. There was a greater number of preterm births (PTB) in unvaccinated women compared with fully vaccinated 29.5% (n = 13) vs 18.2%(n = 2). CONCLUSION: In this descriptive study, unvaccinated pregnant women with RMD and COVID-19 had a greater number of PTB compared with those fully vaccinated against COVID-19. Additionally, the need for COVID-19 pharmacological treatment was uncommon in pregnant women with RMD regardless of vaccination status. These results support active promotion of COVID-19 vaccination in women with RMD who are pregnant or planning a pregnancy