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Replication of a prior quasi-experiment with the same basic design to address reviewer critiques.

Reperfusion therapy with intravenous alteplase and endovascular therapy are effective treatments for selected patients with acute ischemic stroke. Guidelines for treatment are based upon randomized trials demonstrating substantial treatment effects for highly selected patients based on time from stroke onset and imaging features. However, patients beyond the current established guidelines might benefit with lesser but still clinically significant treatment effects. The STAIR (Stroke Treatment Academic Industry Roundtable) XI meeting convened a workgroup to consider the “outer limits” of reperfusion therapy by defining the current boundaries, and exploring optimal parameters and methodology for determining the outer limits. In addition to statistical significance, the minimum clinically important difference should be considered in exploring the limits of reperfusion therapy. Societal factors and quality of life considerations should be incorporated into assessment of treatment efficacy. The threshold for perception of benefit in the medical community may differ from that necessary for the Food and Drug Administration approval. Data from alternative sources such as platform trials, registries and large pragmatic trials should supplement randomized controlled trials to improve generalizability to routine clinical practice. Further interactions between industry and academic centers should be encouraged.

Background and Purpose: The Stroke Treatment Academic Industry Roundtable (STAIR) sponsored an imaging session and workshop during the Stroke Treatment Academic Industry Roundtable XI via webinar on October 1 to 2, 2020, to develop consensus recommendations, particularly regarding optimal imaging at primary stroke centers. Methods: This forum brought together stroke neurologists, neuroradiologists, neuroimaging research scientists, members of the National Institute of Neurological Disorders and Stroke, industry representatives, and members of the US Food and Drug Administration to discuss imaging priorities in the light of developments in reperfusion therapies, particularly in an extended time window, and reinvigorated interest in brain cytoprotection trials. Results: The imaging session summarized and compared the imaging components of recent acute stroke trials and debated the optimal imaging strategy at primary stroke centers. The imaging workshop developed consensus recommendations for optimizing the acquisition, analysis, and interpretation of computed tomography and magnetic resonance acute stroke imaging, and also recommendations on imaging strategies for primary stroke centers. Conclusions: Recent positive acute stroke clinical trials have extended the treatment window for reperfusion therapies using imaging selection. Achieving rapid and high-quality stroke imaging is therefore critical at both primary and comprehensive stroke centers. Recommendations for enhancing stroke imaging research are provided.

BACKGROUND: Postnatal depression and caregiving difficulties adversely affect mothers, infants, and later childhood development. In many countries, resources to help mothers and infants are limited. Online group-based nurse-led interventions have the potential to help address this problem by providing large numbers of mothers with access to professional and peer support during the postnatal period.OBJECTIVE: This study tested the effectiveness of a 4-month online group-based nurse-led intervention delivered when infants were aged 2 to 6 months as compared with standard care outcomes.METHODS: The study was a block randomized control trial. Mothers were recruited at the time they were contacted for the postnatal health check offered to all mothers in South Australia. Those who agreed to participate were randomly assigned to the intervention or standard care. The overall response rate was 63.3% (133/210). Primary outcomes were the level of maternal depressive symptoms assessed with the Edinburgh Postnatal Depression Scale (EPDS) and quality of maternal caregiving assessed using the Parenting Stress Index (PSI; competence and attachment subscales), the Parenting Sense of Competence Scale (PSCS), and the Nursing Child Assessment Satellite Training Scale. Assessments were completed at baseline (mean child age 4.9 weeks [SD 1.4]) and again when infants were aged 8 and 12 months.RESULTS: Outcomes were evaluated using linear generalized estimating equations adjusting for postrandomization group differences in demographic characteristics and the outcome score at baseline. There were no significant differences in the intervention and standard care groups in scores on the PSI competence subscale (P=.69) nor in the PSCS (P=.11). Although the group by time interaction suggested there were differences over time between the EPDS and PSI attachment subscale scores in the intervention and standard care groups (P=.001 and P=.04, respectively), these arose largely because the intervention group had stable scores over time whereas the standard care group showed some improvements between baseline and 12 months. Mothers engaged well with the intervention with at least 60% (43/72) of mothers logging-in once per week during the first 11 weeks of the intervention. The majority of mothers also rated the intervention as helpful and user-friendly.CONCLUSIONS: Mothers reported that the intervention was helpful, and the app was described as easy to use. As such, it appears that support for mothers during the postnatal period, provided using mobile phone technology, has the potential to be an important addition to existing services. Possible explanations for the lack of differences in outcomes for the 2 groups in this study are the failure of many mothers to use key components of the intervention and residual differences between the intervention and standard care groups post randomization.TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12616001732471; http://www.ANZCTR.org.au/ACTRN12616001732471.aspx (archived on WebCite as http://www.webcitation.org/77zo30GDw).

OBJECTIVES: Cerebrovascular disease is among the top 10 causes of death in US children, but risk factors for mortality are poorly understood. Within an international registry, we identify predictors of in-hospital mortality after pediatric arterial ischemic stroke (AIS). METHODS: Neonates (0–28 days) and children (29 days– RESULTS: Fourteen of 915 neonates (1.5%) and 70 of 2273 children (3.1%) died during hospitalization. Of 48 cases with reported causes of death, 31 (64.6%) were stroke-related, with remaining deaths attributed to medical disease. In multivariable analysis, congenital heart disease (odds ratio [OR]: 3.88; 95% confidence interval [CI]: 1.23–12.29; P = .021), posterior plus anterior circulation stroke (OR: 5.36; 95% CI: 1.70–16.85; P = .004), and stroke presentation without seizures (OR: 3.95; 95% CI: 1.26–12.37; P = .019) were associated with in-hospital mortality for neonates. Hispanic ethnicity (OR: 3.12; 95% CI: 1.56–6.24; P = .001), congenital heart disease (OR: 3.14; 95% CI: 1.75–5.61; P < .001), and posterior plus anterior circulation stroke (OR: 2.71; 95% CI: 1.40–5.25; P = .003) were associated with in-hospital mortality for children. CONCLUSIONS: In-hospital mortality occurred in 2.6% of pediatric AIS cases. Most deaths were attributable to stroke. Risk factors for in-hospital mortality included congenital heart disease and posterior plus anterior circulation stroke. Presentation without seizures and Hispanic ethnicity were also associated with mortality for neonates and children, respectively. Awareness and study of risk factors for mortality represent opportunities to increase survival.

Introduction: Hospital-acquired Clostridium difficile infection remains a leading source of morbidity and mortality among hospitalized patients. The purpose of this study was to explore antibiotics use as a risk factor for a cluster of C. difficile cases in trauma-surgical intensive care unit (TSICU

Background Imaging of structural disease in osteoarthritis has traditionally relied on MRI and radiography. Joint space mapping (JSM) can be used to quantitatively map joint space width (JSW) in three dimensions from CT images. Purpose To demonstrate the reproducibility, repeatability, and feasibility of JSM of the knee using weight-bearing CT images. Materials and Methods Two convenience samples of weight-bearing CT images of left and right knees with radiographic Kellgren-Lawrence grades (KLGs) less than or equal to 2 were acquired from 2014 to 2018 and were analyzed retrospectively with JSM to deliver three-dimensional JSW maps. For reproducibility, images of three sets of knees were used for novice training, and then the JSM output was compared against an expert's assessment. JSM was also performed on 2-week follow-up images in the second cohort, yielding three-dimensional JSW difference maps for repeatability. Statistical parametric mapping was performed on all knee imaging data (KLG, 0-4) to show the feasibility of a surface-based analysis in three dimensions. Results Reproducibility (in 20 individuals; mean age, 58 years ± 7 [standard deviation]; mean body mass index, 28 kg/m2 ± 6; 14 women) and repeatability (in nine individuals; mean age, 53 years ± 6; mean body mass index, 26 kg/m2 ± 4; seven women) reached their lowest performance at a smallest detectable difference less than ±0.1 mm in the central medial tibiofemoral joint space for individuals without radiographically demonstrated disease. The average root mean square coefficient of variation was less than 5% across all groups. Statistical parametric mapping (33 individuals; mean age, 57 years ± 7; mean body mass index, 27 kg/m2 ± 6; 23 women) showed that the central-to-posterior medial joint space was significantly narrower by 0.5 mm for each incremental increase in the KLG (threshold P < .05). One knee (KLG, 2) demonstrated a baseline versus 24-month change in its three-dimensional JSW distribution that was beyond the smallest detectable difference across the lateral joint space. Conclusion Joint space mapping of the knee using weight-bearing CT images is feasible, demonstrating a relationship between the three-dimensional joint space width distribution and structural joint disease. It is reliably learned by novice users, can be personalized for disease phenotypes, and can be used to achieve a smallest detectable difference that is at least 50% smaller than that reported to be achieved at the highest performance level in radiography. © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Roemer in this issue.

Objective: To provide insights into complexities of seeking access to state and federal crossjurisdictional data for linkage with the Australian Childhood Immunisation Register (ACIR). We provide recommendations for improving access and receipt of linked datasets involving Australian Government-administered data. Methods: We describe requirements for linking eleven federal and state data sources to establish a national linked dataset for safety evaluation of vaccines. The required data linkage methodology for integrating cross-jurisdictional data sources is also described. Results: Extensive negotiation was required with 18 different agencies for 21 separate authorisations and 12 ethics approvals. Three variations of the 'best practice' linkage model were implemented. Australian Government approval requests spanned nearly four years from initial request for data, with a further year before ACIR data transfer to the linkage agency. Conclusions: Integration of immunisation registers with other data collections is achievable in Australia but infeasible for routine and rapid identification of vaccine safety concerns. Lengthy authorisation requirements, convoluted disparate application processes and inconsistencies in data supplied all contribute to delayed data availability. Implications for public health: Delayed data access for safety surveillance prevents timely epidemiological reviews. Poor responsiveness to safety concerns may erode public confidence, compromising effectiveness of vaccination programs through reduced participation. Refereed/Peer-reviewed

Objective To determine whether differences in combination DTaP vaccine types at 2, 4 and 6 months of age were associated with mortality (all-cause or non-specific), within 30 days of vaccination. Design Observational nationwide cohort study. Setting Linked population data from the Australian Childhood Immunisation Register and National Death Index. Participants Australian infants administered a combination trivalent, quadrivalent or hexavalent DTaP vaccine (DTaP types) between January 1999 and December 2010 at 2, 4 and 6 months as part of the primary vaccination series. The study population included 2.9, 2.6, & 2.3 million children in the 2, 4 and 6 month vaccine cohorts, respectively. Main outcome measures Infants were evaluated for the primary outcome of all-cause mortality within 30 days. A secondary outcome was non-specific mortality (unknown cause of death) within 30 days of vaccination. Non-specific mortality was defined as underlying or other cause of death codes, R95 ‘Sudden infant death syndrome’, R96 ‘Other sudden death, cause unknown’, R98 ‘Unattended death’, R99 ‘Other ill-defined and unspecified cause of mortality’ or where no cause of death was recorded. Results The rate of 30 day all-cause mortality was low and declined from 127.4 to 59.3 deaths per 100,000 person-years between 2 and 6 month cohorts. When compared with trivalent DTaP vaccines, no elevated risk in all-cause or non-specific mortality was seen with any quadrivalent or hexavalent DTaP vaccines, for any cohort. Conclusion Use of routine DTaP combination vaccines with differing disease antigens administered during the first six months of life is not associated with infant mortality.

Background The idea of the ‘30 million word gap’ suggests families from more socioeconomically advantaged backgrounds engage in more verbal interactions with their child than disadvantaged families. Initial findings from the Language in Little Ones (LiLO) study up to 12 months showed no word gap between maternal education groups. Methods Families with either high or low maternal education were purposively recruited into a five-year prospective study. We report results from the first three waves of LiLO when children were 6, 12 and 18 months old. Day-long audio recordings, obtained using the Language Environment Analysis software, provided counts of adult words spoken to the child, child vocalizations and conversational turns. Results By the time children were 18 months old all three measures of talk were 0.5 to 0.7 SD higher among families with more education, but with large variation within education groups. Changes in talk from 6 to 18 months highlighted that families from low educated backgrounds were decreasing the amount they spoke to their children (− 4219.54, 95% CI -6054.13, − 2384.95), compared to families from high educated backgrounds who remained relatively stable across this age period (− 369.13, 95% CI − 2344.57, 1606.30). Conclusions The socioeconomic word gap emerges between 12 and 18 months of age. Interventions to enhance maternal communication, child vocalisations and vocabulary development should begin prior to 18 months.

Objective: The objective of this study was to assess the prevalence and sociodemographic characteristics of cesarean section in Ethiopia. Methods: We used data collected for Ethiopia Demographic and Health Surveys (DHS) conducted in 2000, 2005, 2011, and 2016. A two-stage, stratified, clustered random sampling design was used to gather information from women who gave birth within the 5-year period before each of the surveys. We analyzed the data to identify sociodemographic characteristics associated with cesarean section using log-Poisson regression models. Results: The national cesarean section rate increased from 0.7% in 2000 to 1.9% in 2016, with increases across seven of the eleven administrative regions of Ethiopia. Addis Ababa had the highest cesarean section rate (21.4%) in 2016 and the greatest increase since 2000. In the adjusted analysis, women who gave birth in private health facility had a 78.0% higher risk of cesarean section (adjusted prevalence ratio (aPR) (95% CI) 1.78 (1.22, 2.58)) compared with women who gave birth in public health facility. Having four or more births was associated with a lower risk of cesarean section compared with first births (aPR (95% CI) 0.36 (0.16, 0.79)). Conclusions: The Ethiopian national cesarean section rate is about 2%, but the rate varies widely among administrative regions, suggesting unequal access. Cesarean sections were highest among urban mothers, first births, births to women with higher education, and births to women from the richest quintile of household wealth. Refereed/Peer-reviewed

Background There is evidence that parents from more socioeconomically disadvantaged backgrounds engage in fewer verbal interactions with their child than more advantaged parents. This leads to the so-called, ‘30 million-word gap’. This study aims to investigate the number of words children hear and the number of vocalizations children produce in their first year of life and examines whether these aspects of the early language home environment differ by maternal education. Methods Mothers were recruited into a five-year prospective cohort study and categorized into either high or low maternal education groups. Data was derived from the first two waves of the study, when the children were six and twelve months old. At both waves, children were involved in day-long audio recordings using the Language Environment Analysis software that provided automatic counts of adult words spoken to the child, child vocalizations and conversational turns. Descriptive results are presented by maternal education groups. Results There was large variation within each maternal education group, with the number of adult words spoken to the child ranging from 2958 to 39,583 at six months and 4389 to 45,849 at twelve months. There were no meaningful differences between adult words, child vocalizations or conversational turns across maternal education groups at either wave of data collection. Conclusions These results show that a word gap related to maternal education is not apparent up to twelve months of age. The large variability among both maternal education groups suggests that universal interventions that encourage all parents to talk more to their child may be more appropriate than interventions targeted towards disadvantaged families during the first year of life.

ObjectivesTo quantify emergency department (ED) presentations by individuals within vulnerable populations compared with other adults and the extent to which these are potentially preventable.DesignPeriod prevalence study from 2005-2006 to 2010–2011.SettingPerson-linked, ED administrative records for public hospitals in South Australia.ParticipantsAdults aged 20 or more in South Australia’s metropolitan area presenting to ED and categorised as Refugee and Asylum Seeker Countries of birth (RASC); Aboriginal; those aged 75 years or more; or All others.Main outcome measuresUnadjusted rates of ambulatory care sensitive condition (ACSC), general practitioner (GP)–type presentations and associated direct ED costs among mutually exclusive groups of individuals.ResultsDisparity between RASC and All others was greatest for GP-type presentations (423.7 and 240.1 persons per 1000 population, respectively) with excess costs of $A106 573 (95% CI $A98 775 to $A114 371) per 1000 population. Aboriginal had highest acute ACSC presenter rates (125.8 against 51.6 per 1000 population) with twice the risk of multiple presentations and $A108 701 (95% CI $A374 to $A123 029) per 1000 excess costs. Those aged 75 or more had highest chronic ACSC presenter rates (119.7vs21.1 per 1000), threefold risk of further presentations (incidence rate ratio 3.20, 95% CI 3.14 to 3.26) and excess cost of $A385 (95% CI $A178 160 to $A184 609) per 1000 population.ConclusionsVulnerable groups had excess ED presentations for a range of issues potentially better addressed through primary and community healthcare. The observed differences suggest inequities in the uptake of effective primary and community care and represent a source of excess cost to the public hospital system.

BackgroundThe fourth year of the Sustainable Development Agenda era calls for countries to continue to invest not only in interventions and policies that will promote global equity and sustainability, but also in the monitoring systems required to track progress against these targets. A more pragmatic solution to measuring children’s early development in low and middle income countries in particular, is required. This study explores the psychometric properties of the early Human Capability Index (eHCI), a population measure of holistic development for children aged 3–5 years, designed with the vision of being flexible and feasible for use in low resource and capacity settings.MethodsUtilizing data from seven low and middle income countries: Brazil (n = 1810), China (n = 11,421), Kiribati (n = 8339), Lao People’s Democratic Republic (n = 7493), Samoa (n = 12,191), Tonga (n = 6214), and Tuvalu (n = 549), analyses explored the internal factor structure and reliability of scores produced by the tool within each country.ResultsConfirmatory factor analyses and internal consistency coefficients demonstrated that after local adaptation, translation, and different implementation methods across countries, the eHCI maintained the same factor structure of nine theoretically-based developmental domains: Physical Health, Verbal Communication, Cultural Knowledge, Social and Emotional Skills, Perseverance, Approaches to Learning, Numeracy, Reading, and Writing.ConclusionsFindings support the aims of the eHCI in being adaptable and applicable for use within a range of low and middle income countries to facilitate measurement and monitoring of children’s early development, as is required for the tracking of progress towards the Sustainable Development Agenda.