Ethics and governance for a multi-site study in Australia: Navigating the snakes and ladders.

Multi-site research studies are essential if we are to conduct national research across all Australian jurisdictions. There is widespread agreement among clinicians and researchers that obtaining essential approvals to conduct multi-site research studies in Australia can be complex, bureaucratic and time consuming. Although there is inherent value in the review process, resources and months of valuable research time are often expended long before the study has begun. Using our recent experience for a multi-site, longitudinal paediatric cohort study of children and adolescents who were detained in offshore immigration detention on Nauru, we describe the process of navigating the ethics and governance approval systems. We identify tips for researchers and clinicians conducting multi-site studies, including early consultation with ethics and governance committees, using their recommended templates, anticipating time delays, and commencing time consuming processes as early as permissible. Our recommendations at the systemic level include streamlined and integrated ethics and governance review processes for all Australian jurisdictions, with co-ordinated requests for further information, a standardised approach across all Research Governance Offices, a rapid system for addressing amendments and individualised study support and consultations. Above all, a nationally agreed framework whereby ethics and governance committees across jurisdictions communicate with each other, use the same electronic platform and present a unified process whilst protecting the welfare, rights, dignity and safety of research participants is required. The complexity of the current ethics and governance processes may inadvertently and unintentionally be a barrier to conducting ethical research.

'Smiles and laughter and all those really great things': Nurses' perceptions of good experiences of care for inpatient children and young people with intellectual disability.

AIM: To understand what constitutes a good experience of care for inpatient children and young people with intellectual disability as perceived by nursing staff. DESIGN: Interpretive qualitative study. METHODS: Focus groups with clinical nursing staff from speciality neurological/neurosurgical and adolescent medicine wards across two specialist tertiary children's hospitals in Australia were conducted between March and May 2021. Data analysis followed interpretative analysis methods to develop themes and codes which were mapped to a conceptual model of safe care. RESULTS: Six focus groups with 29 nurses of varying experience levels were conducted over 3 months. Themes and codes were mapped to the six themes of the conceptual model: use rapport, know the child, negotiate roles, shared learning, build trust and relationships, and past experiences. The analysis revealed two new themes that extended the conceptual model to include; the unique role of a paediatric nurse, and joy and job satisfaction, with a third contextual theme, impacts of COVID-19 pandemic restrictions. With the perspectives of paediatric nurses incorporated into the model we have enhanced our model of safe care specifically for inpatient paediatric nursing care of children and young people with intellectual disability. CONCLUSION: Including perceptions of paediatric nurses confirmed the position of the child with intellectual disability being at the centre of safe care, where care is delivered as a partnership between nursing staff, child or young person and their parents/family and the hospital systems and processes. IMPACT: The enhanced model offers a specialized framework for clinical staff and health managers to optimize the delivery of safe care for children and young people with intellectual disability in hospital.

Alpha NSW: What would it take to create a state-wide paediatric population-level learning health system?

BACKGROUND: The health and well-being of children in the first 2000 days has a lasting effect on educational achievement and long-term chronic disease in later life. However, the lack of integration between high-quality data, analytic capacity and timely health improvement initiatives means practitioners, service leaders and policymakers cannot use data effectively to plan and evaluate early intervention services and monitor high-level health outcomes. OBJECTIVE: Our exploratory study aimed to develop an in-depth understanding of the system and clinical requirements of a state-wide paediatric learning health system (LHS) that uses routinely collected data to not only identify where the inequities and variation in care are, but also to also inform service development and delivery where it is needed most. METHOD: Our approach included reviewing exemplars of how administrative data are used in Australia; consulting with clinical, policy and data stakeholders to determine their needs for a child health LHS; mapping the existing data points collected across the first 2000 days of a child's life and geospatially locating patterns of key indicators for child health needs. RESULTS: Our study identified the indicators that are available and accessible to inform service delivery and demonstrated the potential of using routinely collected administrative data to identify the gap between health needs and service availability. CONCLUSION: We recommend improving data collection, accessibility and integration to establish a state-wide LHS, whereby there is a streamlined process for data cleaning, analysis and visualisation to help identify populations in need in a timely manner.

Offshore detention: cross-sectional analysis of the health of children and young people seeking asylum in Australia.

OBJECTIVE: To describe the health and well-being of children and young people (CYP) seeking asylum subjected to Australia's immigration policy of indefinite mandatory detention on Nauru. DESIGN: Cross-sectional analysis of a cohort of CYP seeking asylum. SETTING: Australian paediatric clinicians from 10 health services completed detailed health assessments around the time of transfer from Nauru, mostly to Australia. PARTICIPANTS: Sixty-two CYP who were ≤18 years on entry into offshore immigration detention on Nauru between 2013 and 2019. Mean age at health assessment was 9 years. MAIN MEASURES: Health outcomes were categorised as physical, mental or neurodevelopmental concerns/conditions. Risk and protective factor data were collected using the adverse childhood experiences and refugee-specific adverse childhood experiences tools. RESULTS: Over half of the CYP (n=32, 52%) were held on Nauru for ≥4 years. The vast majority of CYP had physical health (n=55, 89%) and mental health (n=49, 79%) concerns including self-harm or suicidal ideation/attempt (n=28, 45%). Mental health concerns were more likely in CYP who were school-aged (p=0.001), had been held on Nauru for ≥1 year (p=0.01); originated from the Eastern Mediterranean region (p<0.05); witnessed trauma (p<0.05) or had exposure to ≥4 refugee-specific adverse childhood experiences (p<0.05). Neurodevelopmental concerns were seen in eight children (13%). CONCLUSIONS: This study highlights the almost universal physical and mental health difficulties in a sample of CYP who experienced forced migration and were subjected to Australia's offshore immigration detention policy. Immigration detention in recipient countries, a known adverse childhood experience, may contribute to or exacerbate harmful outcomes in CYP seeking asylum.

Feasibility of linking universal child and family healthcare and financial counselling: findings from the Australian Healthier Wealthier Families (HWF) mixed-methods study.

OBJECTIVES: 'Healthier Wealthier Families' (HWF) seeks to reduce financial hardship in the early years by embedding a referral pathway between Australia's universal child and family health (CFH) services and financial counselling. This pilot study investigated the feasibility and short-term impacts of HWF, adapted from a successful Scottish initiative. METHODS: Setting: CFH services in five sites across two states, coinciding with the COVID-19 pandemic. PARTICIPANTS: Caregivers of children aged 0-5 years experiencing financial hardship (study-designed screen). DESIGN: Mixed methods. With limited progress using a randomised trial (RCT) design in sites 1-3 (March 2020-November 2021), qualitative interviews with service providers identified implementation barriers including stigma, lack of knowledge of financial counselling, low financial literacy, research burden and pandemic disruption. This informed a simplified RCT protocol (site 4) and direct referral model (no randomisation, pre-post evaluation, site 5) (June 2021-May 2022). INTERVENTION: financial counselling; comparator: usual care (sites 1-4). Feasibility measures: proportions of caregivers screened, enrolled, followed up and who accessed financial counselling. Impact measures: finances (quantitative) and other (qualitative) to 6 months post-enrolment. RESULTS: 355/434 caregivers completed the screen (60%-100% across sites). In RCT sites (1-4), 79/365 (19%-41%) reported hardship but less than one-quarter enrolled. In site 5, n=66/69 (96%) caregivers reported hardship and 44/66 (67%) engaged with financial counselling; common issues were utility debts (73%), and obtaining entitlements (43%) or material aid/emergency relief (27%). Per family, financial counselling increased income from government entitlements by an average $A6504 annually plus $A784 from concessions, grants, brokerage and debt waivers. Caregivers described benefits (qualitative) including reduced stress, practical help, increased knowledge and empowerment. CONCLUSIONS: Financial hardship screening via CFH was acceptable to caregivers, direct referral was feasible, but individual randomisation was infeasible. Larger-scale implementation will require careful, staged adaptations where CFH populations and the intervention are well matched and low burden evaluation. TRIAL REGISTRATION NUMBER: ACTRN12620000154909.

Study protocol for a real-world evaluation of an integrated child and family health hub for migrant and refugee women.

INTRODUCTION: Continuity of child and family healthcare is vital for optimal child health and development for developmentally vulnerable children. Migrant and refugee communities are often at-risk of poor health outcomes, facing barriers to health service attendance including cultural, language, limited health literacy, discrimination and unmet psychosocial needs. 'Integrated health-social care hubs' are physical hubs where health and social services are co-located, with shared referral pathways and care navigation. AIM: Our study will evaluate the impact, implementation and cost-benefit of the First 2000 Days Care Connect (FDCC) integrated hub model for pregnant migrant and refugee women and their infants. MATERIALS AND METHODS: This study has three components. Component 1 is a non-randomised controlled trial to compare the FDCC model of care with usual care. This trial will allocate eligible women to intervention and control groups based on their proximity to the Hub sites. Outcome measures include: the proportion of children attending child and family health (CFH) nurse services and completing their CFH checks to 12 months of age; improved surveillance of growth and development in children up to 12 months, post partum; improved breastfeeding rates; reduced emergency department presentations; and improved maternal well-being. These will be measured using linked medical record data and surveys. Component 2 will involve a mixed-method implementation evaluation to clarify how and why FDCC was implemented within the sites to inform future roll-out. Component 3 is a within-trial economic evaluation from a healthcare perspective to assess the cost-effectiveness of the Hubs relative to usual care and the implementation costs if Hubs were scaled and replicated. ETHICS AND DISSEMINATION: Ethical approval was granted by the South Eastern Sydney Local Health District Human Research Ethics Committee in July 2021 (Project ID: 020/ETH03295). Results will be submitted for publication in peer-reviewed journals and presented at relevant conferences. TRIAL REGISTRATION NUMBER: ACTRN12621001088831.

Connecting Healthcare with Income Maximisation Services: A Systematic Review on the Health, Wellbeing and Financial Impacts for Families with Young Children.

Financial counselling and income-maximisation services have the potential to reduce financial hardship and its associated burdens on health and wellbeing in High Income Countries. However, referrals to financial counselling services are not systematically integrated into existing health service platforms, thus limiting our ability to identify and link families who might be experiencing financial hardship. Review evidence on this is scarce. The purpose of this study is to review "healthcare-income maximisation" models of care in high-income countries for families of children aged between 0 and 5 years experiencing financial difficulties, and their impacts on family finances and the health and wellbeing of parent(s)/caregiver(s) or children. A systematic review of the MEDLINE, EMBase, PsycInfo, CINAHL, ProQuest, Family & Society Studies Worldwide, Cochrane Library, and Informit Online databases was conducted according to the Preferred Reporting Items for Systemic Reviews and Meta-Analyses (PRISMA) statement. A total of six studies (five unique samples) met inclusion criteria, which reported a total of 11,603 families exposed to a healthcare-income maximisation model. An average annual gain per person of £1661 and £1919 was reported in two studies reporting one Scottish before-after study, whereby health visitors/midwives referred 4805 clients to money advice services. In another UK before-after study, financial counsellors were attached to urban primary healthcare centres and reported an average annual gain per person of £1058. The randomized controlled trial included in the review reported no evidence of impacts on financial or non-financial outcomes, or maternal health outcomes, but did observe small to moderate effects on child health and well-being. Small to moderate benefits were seen in areas relating to child health, preschool education, parenting, child abuse, and early behavioral adjustment. There was a high level of bias in most studies, and insufficient evidence to evaluate the effectiveness of healthcare-income maximisation models of care. Rigorous (RCT-level) studies with clear evaluations are needed to assess efficacy and effectiveness.

Speaking Softly and Listening Hard: The Process of Involving Young Voices from a Culturally and Linguistically Diverse School in Child Health Research.

The involvement of young people in the planning of research continues to be rare, particularly for young people from culturally and linguistically diverse communities. This paper describes our experience in establishing a Youth Research Advisory Group (YRAG) in South West Sydney (SWS), including barriers and successful strategies. One hundred and fifteen students between school Years 7 and 12 (ages 11-18) took part in at least one of five sessions between 2019 and 2021. In total, we carried out 26 YRAG sessions, with between five and 30 students in each. Sessions focused on mapping the health priorities of the participants and co-developing research project proposals related to their health priorities. Our work with students revealed that their main areas of concern were mental health and stress. This led to material changes in our research strategy, to include "Mental Health" as a new research stream and co-develop new mental health-related projects with the students. Important strategies that enabled our research included maintaining flexibility to work seamlessly with organisational and individual preferences, and ensuring our processes were directed by the schools and-most importantly-the students themselves. Strategies such as maintaining an informal context, responding rapidly to student preference, and regularly renegotiating access enabled us to engage with the students to deepen our understanding of their experiences.

Antibiotic Use for Febrile Illness among Under-5 Children in Bangladesh: A Nationally Representative Sample Survey.

Fever in children under five years of age is a common and predominantly self-limiting sign of illness. However, in low- and middle-income countries, antibiotics are frequently used in febrile children, although these children may not benefit from antibiotics. In this study, we explored the prevalence of, and factors associated with, antibiotic use in children under five years old with febrile illness in Bangladesh. We analysed data from the 2017-2018 Bangladesh Demographic and Health Survey to determine the prevalence of antibiotic use in children under five years of age with a febrile illness. We used a causal graph and performed a multivariable logistical regression to identify the factors associated with antibiotic use in children under five years old with febrile illness in Bangladesh. Of the 2784 children aged less than five years with fever included in our analysis, 478 (17%, 95% CI 15% to 19%) received antibiotics. Unqualified sources, including unqualified providers and pharmacies, contributed to 60% of antibiotic prescriptions in children with fever, followed by the private medical sector (29%) and the public sector (23%). The highest use of antibiotics was found in children under six months of age (25%). Children with parents who completed secondary or higher education were more likely to receive antibiotics (adjusted OR (aOR): 2.61 (95% CI 1.63 to 4.16)) than children whose parents did not complete primary education. Educational interventions promoting rational use of antibiotics and improved regulations governing over the counter purchase of antibiotics in Bangladesh may improve antibiotic dispensing practices.

Connecting healthcare with income maximisation services, and their financial, health and well-being impacts for families with young children: a systematic review protocol.

INTRODUCTION: Poverty has far-reaching and detrimental effects on children's physical and mental health, across all geographies. Financial advice and income-maximisation services can provide a promising opportunity for shifting the physical and mental health burdens that commonly occur with financial hardship, yet awareness of these services is limited, and referrals are not systematically integrated into existing healthcare service platforms. We aim to map and synthesise evidence on the impact of healthcare-income maximisation models of care for families of children aged 0-5 years in high-income countries on family finances, parent/caregiver(s) or children's health and well-being. METHODS AND ANALYSIS: To be included in the review, studies must be families (expectant mothers or parents/caregivers) of children who are aged between 0 and 5 years, accessing a healthcare service, include a referral from healthcare to an income-maximisation service (ie, financial counselling), and examine impacts on child and family health and well-being. A comprehensive electronic search strategy will be used to identify studies written in English, published from inception to January 2021, and indexed in MEDLINE, EMBase, PsycINFO, CINAHL, Proquest, Family & Society Studies Worldwide, Cochrane Library, and Informit Online. Search strategies will include terms for: families, financial hardship and healthcare, in various combinations. Bibliographies of primary studies and review articles meeting the inclusion criteria will be searched manually to identify further eligible studies, and grey literature will also be searched. Data on objective and self-reported outcomes and study quality will be independently extracted by two review authors; any disagreements will be resolved through a third reviewer. The protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. ETHICS AND DISSEMINATION: Ethical approval is not required. The results will be disseminated widely via peer-reviewed publication and presentations at conferences related to this field. PROSPERO REGISTRATION NUMBER: CRD42020195985.

The Prevalence and Associated Factors of Depressive Symptoms Among Medical Students in Bangladesh During the COVID-19 Pandemic: A Cross-Sectional Pilot Study.

Background: Whilst very limited studies have demonstrated a correlation between the COVID-19 pandemic and depressive symptoms amongst Bangladeshi medical students, the prevalence and associated factors of depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9) remains widely unknown. Objective: The study aimed to investigate the prevalence and factors associated with depression symptoms among Bangladeshi medical students during the COVID-19 pandemic lockdown period. Method: In this web-based cross-sectional pilot study, medical students' data was collected using the Google Forms web survey platform after obtaining electronic informed consent. A total of 425 medical students were selected using a systematic sampling technique to accumulate depression symptoms and demographic and pandemic-related information. Depression was measured by a self-administered, validated English version of the Patient Health Questionnaire (PHQ-9) tool. The descriptive analysis utilized frequency and percentages, while the stepwise binary logistic regression analysis was performed to investigate the factors associated with depressive symptoms. Result: Among 425 medical students, 62.3% were female, 97.4% unmarried. Almost 80.2% of medical students had mild to severe levels of depressive symptoms as characterized by PHQ-9. A significantly higher probability of depression was found amongst female students (adjusted OR = 1.8), those who struggled to stay away from social media (adjusted OR = 1.8), those who tried to be optimistic for maintaining better psychology (adjusted OR = 11.1), and those who always had a sleeping difficulty in the last 4 weeks (adjusted OR = 8.9). Conclusion: A very high prevalence of depression symptoms among Bangladeshi medical students was found across the majority of socio-demographic variables. The alarming prevalence and associated factors of depression suggests the need for follow-intensity psychosocial interventions designed for medical students during the COVID-19 pandemic.

Asylum seeking children and adolescents in Australian immigration detention on Nauru: a longitudinal cohort study.

INTRODUCTION: Immigration detention has a profound and negative impact on the physical health, mental health, development and social-emotional well-being of children, adolescents and their families. Australian clinicians will report results from detailed health and well-being assessments of asylum seeking children and adolescents who have experienced prolonged immigration detention. METHODS AND ANALYSIS: This is a national, multicentre study with a longitudinal cohort design that will document health and well-being outcomes of the children and adolescents who have been detained in offshore detention on the remote island of Nauru. Outcome measures will be reported from the time arrival in Australia and repeated over a 5-year follow-up period. Measures include demographics, residency history and refugee status, physical health and well-being outcomes (including mental health, development and social-emotional well-being), clinical service utilisation and psychosocial risk and protective factors for health and well-being (eg, adverse childhood experiences). Longitudinal follow-up will capture outcomes over a 5-year period after arrival in Australia. Analysis will be undertaken to explore baseline risk and protective factors, with regression analyses to assess their impact on health and well-being outcomes. To understand how children's outcomes change over time, multilevel regression analysis will be utilised. Structural equation modelling will be conducted to explore the correlation between baseline factors, mediational factors and outcomes to assess trajectories over time. ETHICS AND DISSEMINATION: This research project was approved by the Sydney Children's Hospitals Network Human Research Ethics Committee. Subsequent site-specific approvals have been approved in 5 of the 11 governing bodies where the clinical consultations took place. In order to ensure this research is relevant and sensitive to the needs of the cohort, our research team includes an asylum seeker who has spent time in Australian immigration detention. Results will be presented at conferences and published in peer-reviewed Medline-indexed journals.