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Objective: To estimate household cost of illness (COI) for children with severe pneumonia in Bangladesh.Design: An incidence-based COI study was performed for one episode of childhood severe pneumonia from a household perspective. Face-to-face interviews collected data on socioeconomic, resource use and cost from caregivers. A micro-costing bottom-up approach was applied to calculate medical, non-medical and time costs. Multiple regression analysis was applied to explore the factors associated with COI. Sensitivity analysis explored the robustness of cost parameters.Setting: Four urban and rural study sites from two districts in Bangladesh.Patients: Children aged 2-59 months with severe pneumonia.Results: 1472 children with severe pneumonia were enrolled between November 2015 and March 2019. The mean age of children was 12 months (SD ±10.2) and 64% were male. The mean household cost per episode was US$147 (95% CI 141.1 to 152.7). Indirect costs were the main cost drivers (65%, US$96). Household costs for the poorest income quintile were lower in absolute terms, but formed a higher proportion of monthly income. COI was significantly higher if treatment was received from urban health facilities compared with rural health facilities (difference US$84.9, 95% CI 73.3 to 96.3). Child age, household income, healthcare facility and hospital length of stay (LoS) were significant predictors of household COI. Costs were most sensitive to hospital LoS and productivity loss.Conclusions: Severe pneumonia in young children is associated with high household economic burden and cost varies significantly across socioeconomic parameters. Management strategies with improved accessibility are needed particularly for the poor to make treatment affordable in order to reduce household economic burden. [ABSTRACT FROM AUTHOR]

Introduction The first years of school are critical in establishing a foundation for positive long-term academic, social and well-being outcomes. Mindfulness-based interventions may help students transition well into school, but few robust studies have been conducted in this age group. We aim to determine whether compared with controls, children who receive a mindfulness intervention within the first years of primary school have better: (1) immediate attention/short-term memory at 18 months post-randomisation (primary outcome); (2) inhibition, working memory and cognitive flexibility at 18 months postrandomisation; (3) socio-emotional well-being, emotionregulation and mental health-related behaviours at 6 and 18 months post-randomisation; (4) sustained changes in teacher practice and classroom interactions at 18 months post-randomisation. Furthermore, we aim to determine whether the implementation predicts the efficacy of the intervention, and the cost effectiveness relative to outcomes. Methods and analysis This cluster randomised controlled trial will be conducted in 22 primary schools in disadvantaged areas of Melbourne, Australia. 826 students in the first year of primary school will be recruited to detect between groups differences of Cohen’s d=0.25 at the 18-month follow-up. Parent, teacher and child-assessment measures of child attention, emotion-regulation, executive functioning, socio-emotional well-being, mental healthrelated behaviour and learning, parent mental well-being, teacher well-being will be collected 6 and 18 months postrandomisation. Implementation factors will be measured throughout the study. Intention-to-treat analyses, accounting for clustering within schools and classes, will adopt a two-level random effects linear regression model to examine outcomes for the intervention versus control students. Unadjusted and analyses adjusted for baseline scores, baseline age, gender and family socioeconomic status will be conducted. Ethics and dissemination Ethics approval has been received by the Human Research Ethics Committee at the University of Melbourne. Findings will be reported in peerreview publications, national and international conference presentations and research snapshots directly provided to participating schools and families. [ABSTRACT FROM AUTHOR]

Objective: To investigate the associations of hearing thresholds and slight to mild hearing loss with academic, behavioural and quality of life outcomes in children at a population level.Methods: Design and participants:children aged 11-12 years in the population-based cross-sectional Child Health CheckPoint study within the Longitudinal Study of Australian Children. Audiometry:mean hearing threshold across 1, 2 and 4 kHz (better and worse ear); slight/mild hearing loss (threshold of 16-40 decibels hearing loss (dB HL)). Outcomes: National Assessment Program - Literacy and Numeracy, language, teacher-reported learning, parent and teacher reported behaviour and self-reported quality of life. Analysis:linear regression quantified associations of hearing threshold/loss with outcomes.Results: Of 1483 children (mean age 11.5 years), 9.2% and 13.1% had slight/mild bilateral and unilateral hearing loss, respectively. Per SD increment in better ear threshold (5.7 dB HL), scores were worse on several academic outcomes (eg, reading 0.11 SD, 95% CI 0.05 to 0.16), parent-reported behaviour (0.06 SD, 95% CI 0.01 to 0.11) and physical (0.09 SD, 95% CI 0.04 to 0.14) and psychosocial (0.06 SD, 95% CI 0.01 to 0.11) Pediatric Quality of Life Inventory (PedsQL). Compared with normally hearing children, children with bilateral slight/mild losses scored 0.2-0.3 SDs lower in sentence repetition, teacher-reported learning and physical PedsQL but not other outcomes. Similar but attenuated patterns were seen in unilateral slight/mild losses.Conclusions: Hearing thresholds and slight/mild hearing loss showed small but important associations with some child outcomes at 11-12 years. Justifying hearing screening or intervention at this age would require better understanding of its longitudinal and indirect effects, alongside effective management and appropriate early identification programmes. [ABSTRACT FROM AUTHOR]

Objectives To describe the distribution of health-related quality of life (HRQL) in a national sample of Australian children aged 11-12 years and their parents, and examine associations within parent-child dyads. Design The Child Health CheckPoint, a population-based cross-sectional study nested between waves 6 and 7 of the Longitudinal Study of Australian Children (LSAC). Setting Assessment centres in seven Australian cities and eight regional towns, or home visit; February 2015 to March 2016. Participants Of all participating CheckPoint families (n=1874), 1853 children (49.0% girls) and 1863 parents (87.7% mothers) with HRQL data were included (1786 pairs). Outcome measures HRQL was self-reported using preference-based (Child Health Utility 9Dimension, CHU9D) and non-preference-based (Pediatric Quality of Life, PedsQL V.4.0) measures for children and preference-based measures for parents (CHU9D; Assessment of Quality of Life 8 Dimension, AQoL-8D). Utility scores from preference-based measures were calculated using existing Australian algorithms to present a score on a 0-1 scale, where 1 represents full health. Parent-child concordance was assessed using Pearson's correlation coefficients and adjusted linear regression models. Survey weights and methods were applied to account for LSAC's complex sample design, stratification and clustering within postcodes. Results Children's means and SD were 0.81 (SD 0.16) for CHU9D and 78.3 (SD 13.03) for PedsQL. In adults, mean HRQL for AQoL-8D and CHU9D were 0.78 (SD 0.16) and 0.89 (SD 0.10), respectively. Mean HRQL was similar for boys and girls, but slightly higher for fathers than mothers. The Pearson correlation coefficient for parent-child CHU9D values was 0.13 (95% CI 0.09 to 0.18). Percentiles and concordance are presented for both samples for males and females separately and together. Conclusions We provide Australian paediatric population values for HRQL measures, and the first national CHU9D values for mid-life adults. At age 11-12 years in this relatively healthy sample, parent-child concordance in HRQL was small. [ABSTRACT FROM AUTHOR]

Objective: In a national study of Australian children aged 11-12 years old, we examined the (1) prevalence and characteristics of hearing loss, (2) its demographic risk factors and (3) evidence for secular increases since 1990.Methods: This is a cross-sectional CheckPoint wave within the Longitudinal Study of Australian Children. 1485 children (49.8% retention; 49.7% boys) underwent air-conduction audiometry. Aim 1: hearing loss (≥16 decibels hearing level (dB HL)) was defined in four ways to enable prior/future comparisons: high Fletcher Index (mean of 1, 2 and 4 kHz; primary outcome relevant to speech perception), four-frequency (1, 2, 4 and 8 kHz), lower frequency (1 and 2 kHz) and higher frequency (4 and 8 kHz); aim 2: logistic regression of hearing loss by age, gender and disadvantage index; and aim 3: P for trend examining CheckPoint and reported prevalence in studies arranged by date since 1990.Results: For high Fletcher Index, the prevalence of bilateral and unilateral hearing loss ≥16 dB HL was 9.3% and 13.3%, respectively. Slight losses (16-25 dB HL) were more prevalent than mild or greater (≥26 dB HL) losses (bilateral 8.5% vs 0.8%; unilateral 12.5% vs 0.9%), and lower frequency more prevalent than higher frequency losses (bilateral 11.0% vs 6.9%; unilateral 15.4% vs 11.5%). Demographic characteristics did not convincingly predict hearing loss. Prevalence of bilateral/unilateral lower and higher frequency losses ≥16 dB HL has risen since 1990 (all P for trend <0.001).Conclusions and Relevance: Childhood hearing loss is prevalent and has risen since 1990. Future research should investigate the causes, course and impact of these changes. [ABSTRACT FROM AUTHOR]

Introduction: By the time children start school, inequities in learning, development and health outcomes are already evident. Sustained nurse home visiting (SNHV) offers a potential platform for families experiencing adversity, who often have limited access to services. While SNHV programmes have been growing in popularity in Australia and internationally, it is not known whether they can improve children's learning and development when offered via the Australian service system. The right@home trial aims to investigate the effectiveness of an SNHV programme, offered to women from pregnancy to child age 2 years, in improving parent care of and responsivity to the child, and the home learning environment. Methods and analysis: Pregnant Australian women (n=722) are identified after completing a screening survey of 10 factors known to predict children's learning and development (eg, young pregnancy, poor mental or physical health, lack of support). Consenting women--surveyed while attending clinics at 10 hospitals in Victoria and Tasmania--are enrolled if they report having 2 or more risk factors. The intervention comprises 25 home visits from pregnancy to 2 years, focusing on parent care of the child, responsivity to the child and providing a good quality home learning environment. The standard, universal, Australian child and family health service provides the comparator (control). Primary outcome measures include a combination of parent-reported and objective assessments of children's sleep, safety, nutrition, parenting styles and the home learning environment, including the Home Observation of the Environment Inventory and items adapted from the Longitudinal Study of Australian Children. Ethics and dissemination: This study is approved by the Royal Children's Hospital Human Research Ethics Committees (HREC 32296) and site-specific HRECs. The investigators and sponsor will communicate the trial results to stakeholders, participants, healthcare professionals, the public and other relevant groups via presentations and publications. [ABSTRACT FROM AUTHOR]

Objectives: The Teeth Tales trial aimed to establish a model for child oral health promotion for culturally diverse communities in Australia. Design: An exploratory trial implementing a community-based child oral health promotion intervention for Australian families from migrant backgrounds. Mixed method, longitudinal evaluation. Setting: The intervention was based in Moreland, a culturally diverse locality in Melbourne, Australia. Participants: Families with 1-4-year-old children, self-identified as being from Iraqi, Lebanese or Pakistani backgrounds residing in Melbourne. Participants residing close to the intervention site were allocated to intervention. Intervention: The intervention was conducted over 5 months and comprised community oral health education sessions led by peer educators and follow-up health messages. Outcome measures: This paper reports on the intervention impacts, process evaluation and descriptive analysis of health, knowledge and behavioural changes 18 months after baseline data collection. Results: Significant differences in the Debris Index (OR=0.44 (0.22 to 0.88)) and the Modified Gingival Index (OR=0.34 (0.19 to 0.61)) indicated increased tooth brushing and/or improved toothbrushing technique in the intervention group. An increased proportion of intervention parents, compared to those in the comparison group reported that they had been shown how to brush their child's teeth (OR=2.65 (1.49 to 4.69)). Process evaluation results highlighted the problems with recruitment and retention of the study sample (275 complete case families). The child dental screening encouraged involvement in the study, as did linking attendance with other community/cultural activities. Conclusions: The Teeth Tales intervention was promising in terms of improving oral hygiene and parent knowledge of tooth brushing technique. Adaptations to delivery of the intervention are required to increase uptake and likely impact. A future cluster randomised controlled trial would provide strongest evidence of effectiveness if appropriate to the community, cultural and economic context. Trial registration number: Australian New Zealand Clinical Trials Registry (ACTRN12611000532909). [ABSTRACT FROM AUTHOR]

Introduction: Many maternity providers recommend that women with diabetes in pregnancy express and store breast milk in late pregnancy so breast milk is available after birth, given (1) infants of these women are at increased risk of hypoglycaemia in the first 24 h of life; and (2) the delay in lactogenesis II compared with women without diabetes that increases their infant's risk of receiving infant formula. The Diabetes and Antenatal Milk Expressing (DAME) trial will establish whether advising women with diabetes in pregnancy (pre-existing or gestational) to express breast milk from 36 weeks gestation increases the proportion of infants who require admission to special or neonatal intensive care units (SCN/NICU) compared with infants of women receiving standard care. Secondary outcomes include birth gestation, breastfeeding outcomes and economic impact. Methods and analysis: Women will be recruited from 34 weeks gestation to a multicentre, two arm, unblinded randomised controlled trial. The intervention starts at 36 weeks. Randomisation will be stratified by site, parity and diabetes type. Women allocated to the intervention will be taught expressing and encouraged to hand express twice daily for 10 min and keep an expressing diary. The sample size of 658 (329 per group) will detect a 10% difference in proportion of babies admitted to SCN/NICU (85% power, a 0.05). Data are collected at recruitment (structured questionnaire), after birth (abstracted from medical record blinded to group), and 2 and 12 weeks postpartum (telephone interview). Data analysis: the intervention group will be compared with the standard care group by intention to treat analysis, and the primary outcome compared using %2 and ORs. Ethics and dissemination: Research ethics approval will be obtained from participating sites. Results will be published in peer-reviewed journals and presented to clinicians, policymakers and study participants. [ABSTRACT FROM AUTHOR]

Introduction: Inequalities are evident in early childhood caries rates with the socially disadvantaged experiencing greater burden of disease. This study builds on formative qualitative research, conducted in the Moreland/Hume local government areas of Melbourne, Victoria 2006-2009, in response to community concerns for oral health of children from refugee and migrant backgrounds. Development of the community-based intervention described here extends the partnership approach to cogeneration of contemporary evidence with continued and meaningful involvement of investigators, community, cultural and government partners. This trial aims to establish a model for child oral health promotion for culturally diverse communities in Australia. Methods and analysis: This is an exploratory trial implementing a community-based child oral health promotion intervention for Australian families from refugee and migrant backgrounds. Families from an Iraqi, Lebanese or Pakistani background with children aged 1-4 years, residing in metropolitan Melbourne, were invited to participate in the trial by peer educators from their respective communities using snowball and purposive sampling techniques. Target sample size was 600. Moreland, a culturally diverse, inner-urban metropolitan area of Melbourne, was chosen as the intervention site. The intervention comprised peer educator led community oral health education sessions and reorienting of dental health and family services through cultural Competency Organisational Review (CORe). Ethics and dissemination: Ethics approval for this trial was granted by the University of Melbourne Human Research Ethics Committee and the Department of Education and Early Childhood Development Research Committee. Study progress and output will be disseminated via periodic newsletters, peer-reviewed research papers, reports, community seminars and at National and International conferences. Trial registration number: Australian New Zealand Clinical Trials Registry (ACTRN12611000532909). [ABSTRACT FROM AUTHOR]

Introduction: The transition to primary school appears crucial for a child's future academic and psychological well-being. Addressing conditions which negatively affect children during this period, such as poor sleep, may improve these outcomes. Sleep problems are common and in a previous efficacy randomised controlled trial, we demonstrated that sleep problems can be identified and improved using schoolbased screening followed by a brief behavioural intervention. This trial will determine whether the same intervention is beneficial and cost-effective when delivered by an existing school-based health workforce. Methods/design: We will recruit 334 children with sleep problems from approximately 40 schools after screening for behavioural sleep problems in the first year of formal education (Grade Prep). Schools in Melbourne, Australia will be invited to participate from a randomly ordered list of eligible schools and we will approach all caregivers of Grade Prep children. Children who have a parent-reported moderate or severe sleep problem will be randomised into either 'usual care' or 'intervention' groups. Trained nurses from the Primary School Nursing programme will deliver the sleep intervention programme. Intervention: Two to three contacts between the nurse and the parent; initial 45 min face-to-face meeting or phone call, 15 min phone call 2 weeks later and an optional second 30 min face-to-face meeting. Follow-up: 6 and 12 months postrandomisation using parent and teacher surveys and child face-to-face assessments. Primary outcome: child psychosocial functioning at 6 months. Secondary outcomes: child psychosocial functioning at 12 months and child sleep, behaviour, working memory, academic achievement and parent mental health at 6 and 12 months. Cost-effectiveness analysis will compare incremental costs to difference in child psychosocial functioning at 6 months. Registration: International Standard Randomised Controlled Trial Number Register (ISRCTN92448857). [ABSTRACT FROM AUTHOR]

Objectives: To determine whether a community-delivered intervention targeting infant sleep problems improves infant sleep and maternal well-being and to report the costs of this approach to the healthcare system. Design: Cluster randomised trial. Setting: 49 Maternal and Child Health (MCH) centres (clusters) in Melbourne, Australia. Participants: 328 mothers reporting an infant sleep problem at 7 months recruited during October-November 2003. Intervention: Behavioural strategies delivered over individual structured MCH consultations versus usual care. Main outcome measures: Maternal report of infant sleep problem, depression symptoms (Edinburgh Postnatal Depression Scale (EPDS)), and SF-12 mental and physical health scores when infants were 10 and 12 months old. Costs included MCH sleep consultations, other healthcare services and intervention costs. Results: Prevalence of infant sleep problems was lower in the intervention than control group at 10 months (56% vs 68%; adjusted OR 0.58 (95% CI: 0.36 to 0.94)) and 12 months (39% vs 55%; adjusted OR 0.50 (0.31 to 0.80)). EPDS scores indicated less depression at 10 months (adjusted mean difference -1.4 (-2.3 to -0.4) and 12 months (-1.7 (-2.6 to -0.7)). SF-12 mental health scores indicated better health at 10 months (adjusted mean difference 3.7 (1.5 to 5.8)) and 12 months (3.9 (1.8 to 6.1)). Total mean costs including intervention design, delivery and use of non-MCH nurse services were £96.93 and £116.79 per intervention and control family, respectively. Conclusions: Implementing this sleep intervention may lead to health gains for infants and mothers and resource savings for the healthcare system. Trial registration: Current Controlled Trial Registry, number ISRCTN48752250 (registered November 2004). [ABSTRACT FROM AUTHOR]

Insignificant or modest findings in intervention trials may be attributable to poorly designed or theorised interventions, poorly implemented interventions, or inadequate evaluation methods. The pre-existing context may also account for the effects observed. A combination of qualitative and quantitative methods is outlined that will permit the determination of how context level factors might modify intervention effectiveness, within a cluster randomised community intervention trial to promote the health of mothers with new babies. The methods include written and oral narratives, key informant interviews, impact logs, and inter-organisational network analyses. Context level factors, which may affect intervention uptake, success, and sustainability are the density of inter-organisational ties within communities at the start of the intervention, the centrality of the primary care agencies expected to take a lead with the intervention, the extent of context-level adaptation of the intervention, and the amount of local resources contributed by the participating agencies. Investigation of how intervention effects are modified by context is a new methodological frontier in community intervention trial research. [ABSTRACT FROM AUTHOR]

Abstract Objective: To assess the evidence for the effectiveness of increasing numbers of drugs in antiretroviral combination therapy. Design: Systematic review, meta-analysis, and meta-regression of fully reported randomised controlled trials. All studies included compared quadruple versus triple therapy, triple versus double therapy, double versus monotherapy, or monotherapy versus placebo or no treatment. Participants: Patients with any stage of HIV infection who had not received antiretroviral therapy. Main outcome measures: Changes in disease progression or death (clinical outcomes); CD4 count and plasma viral load (surrogate markers). Search strategy: Six electronic databases, including Medline, Embase, and the Cochrane Library, searched up to February 2001. Results: 54 randomised controlled trials, most of good quality, with 66 comparison groups were included in the analysis. For both the clinical outcomes and surrogate markers, combinations with up to and including three (triple therapy) were progressively and significantly more effective. The odds ratio for disease progression or death for triple therapy compared with double therapy was 0.6 (95% confidence interval 0.5 to 0.8). Heterogeneity in effect sizes was present in many outcomes but was largely related to the drugs used and trial quality. Conclusions: Evidence from randomised controlled trials supports the use of triple therapy. Research is needed on the effectiveness of quadruple therapies and the relative effectiveness of specific combinations of drugs. [ABSTRACT FROM AUTHOR]

The article presents an overview of complex interventions that are used in many medical settings such as hospitals. A discussion of the differences between complex interventions and complex systems that are used in medical settings is presented. The role complexity plays in evaluating the effectiveness of man non-drug interventions that are used in medical settings is discussed. The role complexity plays in the economic evaluation of interventions in medical settings including hospitals is examined.

The article focuses on the result of the trial on the use of six session parent-toddler language promotion programme to toddlers at ages two and three years with low spoken vocabulary. It states that the trial was conducted using the Preschool Language Scale-4 Expressive Communication and Auditory Comprehension scales. The result of the controlled trial shows that children at two years have a retention for intervention of 94% and 96% for control while 89% for both groups at age three years.

The article offers information on the LEAP 2 randomized controlled trial which investigated the association between improved body mass index and primary care surveillance and intervention for overweight or obese children. It briefly describes the study's design. The study was conducted in Melbourne, Victoria, and enrolled six general practitioners (GP) and 3958 children aged 5 years, 0 months to 9 years 11 months visited by the GP from May 2005 to July 2006. Also noted are primary outcomes, main results and the role of chance.