User-driven instructions reduce errors in child restraint use: a randomised controlled trial in Sydney, Australia.

BACKGROUND AND OBJECTIVES: Crash injury risk is reduced when a child correctly uses an appropriate restraint; however, incorrect restraint use remains widespread. The aim of this study was to determine whether product information developed using a user-driven approach increases correct child restraint use. METHODS: We conducted a two-arm double-blinded parallel randomised controlled trial in New South Wales, Australia 2019-2021. Participants were current drivers who were either an expectant parent or a parent of at least one child residing in the greater Sydney metropolitan area who were interested in purchasing a new child restraint. The intervention was user-driven product information consisting of instructions printed on an A3 sheet of paper, swing tags with key reminders and a video accessed via Quick Response codes printed on the materials. The control group received a postcard summarising legal child restraint requirements. The primary outcome was the correctness of child restraint use observed during home visit approximately 6 months after restraint purchase. Correct use was defined as no serious error or <2 minor errors. The secondary outcome was a count of observed errors. RESULTS: 427 participants were recruited. Home visits were conducted for 372 (190 intervention and 182 control). Correct use was more common in the intervention group (37.4%) compared with the control group (24.2%, p=0.006). Participants receiving the intervention were 1.87 times more likely to correctly use their restraint than those in the control group (95% CI 1.19 to 2.93). CONCLUSIONS: The results provide evidence for the effectiveness of user-driven instructions as a countermeasure to restraint misuse. TRIAL REGISTRATION NUMBER: ACTRN12617001252303.

Regular whole blood donation and gastrointestinal, breast, colorectal and haematological cancer risk among blood donors in Australia.

BACKGROUND AND OBJECTIVES: Several studies have suggested that blood donors have lower risk of gastrointestinal and breast cancers, whereas some have indicated an increased risk of haematological cancers. We examined these associations by appropriately adjusting the 'healthy donor effect' (HDE). MATERIALS AND METHODS: We examined the risk of gastrointestinal/colorectal, breast and haematological cancers in regular high-frequency whole blood (WB) donors using the Sax Institute's 45 and Up Study data linked with blood donation and other health-related data. We calculated 5-year cancer risks, risk differences and risk ratios. To mitigate HDE, we used 5-year qualification period to select the exposure groups, and applied statistical adjustments using inverse probability weighting, along with other advanced doubly robust g-methods. RESULTS: We identified 2867 (42.4%) as regular high-frequency and 3888 (57.6%) as low-frequency donors. The inverse probability weighted 5-year risk difference between high and low-frequency donors for gastrointestinal/colorectal cancer was 0.2% (95% CI, -0.1% to 0.5%) with a risk ratio of 1.25 (0.83-1.68). For breast cancer, the risk difference was -0.2% (-0.9% to 0.4%), with a risk ratio of 0.87 (0.48-1.26). Regarding haematological cancers, the risk difference was 0.0% (-0.3% to 0.5%) with a risk ratio of 0.97 (0.55-1.40). Our doubly robust estimators targeted minimum loss-based estimator (TMLE) and sequentially doubly robust (SDR) estimator, yielded similar results, but none of the findings were statistically significant. CONCLUSION: After applying methods to mitigate the HDE, we did not find any statistically significant differences in the risk of gastrointestinal/colorectal, breast and haematological cancers between regular high-frequency and low-frequency WB donors.

Spatial patterns of maternal and neonatal continuum of care use and its correlations with women's empowerment.

BACKGROUND: The continuum of care (CoC) in maternal health refers to the continuity of individual reproductive health care across the antenatal, intrapartum, and postnatal periods. The CoC is an indicator of the quality of maternal and newborn health outcomes and women's empowerment is crucial to improving maternal and neonatal health service access and utilisation. OBJECTIVE: To examine the spatial patterns of continuum of care use for maternal and neonatal health services and its correlation with women's empowerment. METHODS: We analysed data from the Ethiopian Demographic and Health Surveys (EDHS) of 2011 and 2016. All women aged 15-49 who had live births in the preceding five years of the DHS surveys were included in the analysis. We measured the continuum of care using the modified co-coverage index (CoCI), which consisted of six indicators. Women's empowerment was assessed using a validated survey-based Women's Empowerment (SWPER) index. We used the Getis-Ord-Gi* spatial analysis tool to portray locations with clusters of CoC service use and spatial correlations between CoC use and women empowerment. RESULTS: None of the newborn-mother pairs in the 2011 survey received the entire continuum of care and only 2.5% of newborn-mother pairs received the full range of continuum of care services in the 2016 survey. In 2016, 6.9% of mother-newborn pairs received the basic CoC services (four or more antenatal care [ANC] visits, skilled birth attendance [SBA], and postnatal care [PNC]), and no mother-newborn pair received all three services at the same time in 2011. The Amhara, Afar, and Somali regional states had the least CoC service use in both surveys. There was a positive spatial correlation between CoC use and women's empowerment domains. CONCLUSION: Our analysis showed that the use of four or more ANC visits, SBS, newborn PNC, Bacillus Calmette-Guérin (BCG) vaccine uptake, and tetanus toxoid protection at birth were low in Ethiopia. Women empowerment domains were found to have a positive spatial correlation with CoC services use. To improve and preserve continuity of care, it is critical to leverage every maternal health facility encounter to encourage sustained service usage at each step of the continuum. Government policies should prioritise women's empowerment and raise public awareness of maternity services.

Health of refugees settled in Australia over time and generations: a transformative mixed methods study protocol.

BACKGROUND: Refugees resettled in Australia may experience significant physical, mental and emotional health issues on arrival and difficulty accessing mainstream healthcare that often demands specialised services. It is not known if and how refugee health needs and service use change over time and generations, how this compares with the broader Australian population and what level of resourcing is required to maintain specialised services. There is also a significant knowledge gap concerning the resources and skills of refugees that can be harnessed to sustain the health and well-being of individuals and communities. Such knowledge gaps impede the ability of the health system to deliver responsive, efficient, acceptable and cost-effective care and services and limit the engagement of refugees in the coproduction of these services. METHODS: This study will be the first to provide comprehensive, longitudinal, population-based evidence of refugee health, service use and the accumulated resources or assets related to positive health and well-being (compared with data on deficits, illness and death) across the lifespan and generations. This will enable a comprehensive understanding of the relationships among assets, health status, service gaps and behaviours. We will identify the assets contributing to increased capacities to protect and promote health. This evidence is essential for planning health prevention programmes.This project has three phases: (1) employ national linked datasets to examine the health and social outcomes of refugees in Australia; (2) engage with refugees in a participatory manner to map the social, economic, organisational, physical and cultural assets in their communities and deliver an integrated model of health; and (3) codesign a roadmap of agreed actions required to attain health and well-being in communities and indicators to assess outcomes. ETHICS AND DISSEMINATION: Ethics and procedures-phase I:Ethical approval for phase I was gained from the Australian Bureau of Statistics (ABS) for Person Level Integrated Data Asset microdata (unit record data) via the ABS DataLab and the NSW Population and Health Services Research Ethics Committee (2023ETH01728), which can provide a single review of multijurisdictional data linkage research projects under the National Mutual Acceptance Scheme. This will facilitate approval for the Victorian and ACT datasets. The ABS will be the integrating/linkage authority. The Centre for Health Record Linkage (CHeReL) and the Victorian Data Linkage Unit will prepare a data extract representing all data records from the dataset to provide to the ABS for linkage.Ethics and procedures-phases 2 and 3:Written consent will be obtained from all participants, as well as consent to publish. We have obtained ethical approval from the University of Technology Sydney Medical Research Ethics Committee; however, as we deepen our consultation with community members and receive input from expert stakeholders, we will likely seek amendments to hone the survey and World Café questions. We will also need to provide flexible offerings that may extend to individual interviews and online interactions. DISCUSSION: This innovative approach will empower refugees and put them at the centre of their health and decision-making.

The 1-min sit-to-stand test as a screening tool to assess exercise-induced oxygen desaturation in normoxemic people with interstitial lung disease.

BACKGROUND: In patients with interstitial lung disease (ILD), exercise-induced desaturation during the 6-min walk test (6MWT), specifically nadir oxygen saturation (nSpO2) of ≤88 % is a negative prognostic marker. As the 6MWT is often impractical for ILD patients, the aim of this study is to compare the 1-min sit-to-stand test (1minSTS) with the 6MWT to detect exercise-induced desaturation. METHODS: Participants were recruited from a tertiary referral clinic with both tests performed on the same day. Utilising Bland-Altman analysis, the relationship between nSpO2 on 1minSTS and 6MWT was determined. An area under the receiver operating characteristic curve (AUC) determined the ability of nSpO2 on 1minSTS test to predict SpO2 ≤88 % on 6MWT. RESULTS: Fifty participants completed the study (idiopathic pulmonary fibrosis n = 24, 48 %; connective tissue disease associated ILD n = 20, 40 %; other ILD n = 6, 12 %). Mean (SD) FVC%pred was 73 ± 16 %, mean DLCO%pred 57 ± 16 % and resting SpO2 99 ± 1 %. The 1minSTS resulted in less exercise-induced oxygen desaturation, with a median IQR nSpO2 of 95 % (89-98) and 93 % (85-96) respectively (p < 0.001). Moderate agreement was determined between the nSpO2 on both tests, with a mean difference of 3.2 % [-14 to +3.0 %]. The 1minSTS test accurately identified participants with nSpO2 ≤88 % on 6MWT (AUC 0.96). Oxygen desaturation ≤94 % during the 1minSTS test provided 100 % sensitivity and 87 % specificity for oxygen desaturation ≤88 % at 6MWT. CONCLUSION: This study demonstrates that exercise-induced oxygen desaturation during the 1minSTS test correlates with oxygen desaturation on 6MWT. The 1minSTS may be a practical screening tool for ILD patients who would benefit from further exercise testing.

Has Active Surveillance for Prostate Cancer Become Safer? Lessons Learned from a Global Clinical Registry.

BACKGROUND AND OBJECTIVE: Active surveillance (AS) has evolved into a widely applied treatment strategy for many men around the world with low-risk prostate cancer (or in selected cases intermediate-risk disease). Here, we report on the safety and acceptability of AS, and treatment outcomes for low- and intermediate-risk tumours over time in 14 623 men with follow-up of over 6 yr. METHODS: Clinical data from 26 999 men on AS from 25 cohorts in 15 countries have been collected in an international database from 2000 onwards. KEY FINDINGS AND LIMITATIONS: Across our predefined four time periods of 4 yr each (covering the period 2000-2016), there was no significant change in overall survival (OS). However, metastasis-free survival (MFS) rates have improved since the second period and were excellent (>99%). Treatment-free survival rates for earlier periods showed a slightly more rapid shift to radical treatment. Over time, there was a constant proportion of 5% of men for whom anxiety was registered as the reason for treatment alteration. There was, however, also a subset of 10-15% in whom treatment was changed, for which no apparent reason was available. In a subset of men (10-15%), tumour progression was the trigger for treatment. In men who opted for radical treatment, surgery was the most common treatment modality. In those men who underwent radical treatment, 90% were free from biochemical recurrence at 5 yr after treatment. CONCLUSIONS AND CLINICAL IMPLICATIONS: Our study confirms that AS was a safe management option over the full duration in this large multicentre cohort with long-term follow-up, given the 84.1% OS and 99.4% MFS at 10 yr. The probability of treatment at 10 yr was 20% in men with initial low-risk tumours and 31% in men with intermediate-risk tumours. New diagnostic modalities may improve the acceptability of follow-up using individual risk assessments, while safely broadening the use of AS in higher-risk tumours. PATIENT SUMMARY: Active surveillance (AS) has evolved into a widely applied treatment strategy for many men with prostate cancer around the world. In this report, we show the long-term safety of following AS for men with low- and intermediate-risk prostate cancer. Our study confirms AS as a safe management option for low- and intermediate-risk prostate cancer. New diagnostic modalities may improve the acceptability of follow-up using individual risk assessments, while safely broadening the use of AS in higher-risk tumours.

"It's about Rights": The Bunya Project's Indigenous Australian Voices on Health Care Curricula and Practice.

Indigenous community-controlled health care organizations provide timely, sustained, and culturally safe care. However, their expertise is often excluded from health professional education. This limits the transfer of knowledges and protocols to future practitioners-those positioned to shape health care systems and practices that could achieve the health rights of Indigenous people and reduce health and social inequities. In Australia, despite national government commitments to transforming curricula, services, and systems related to Indigenous health, health care training organizations such as universities generally have low numbers of Indigenous staff and few strategies to engage Indigenous experts. The authors of this paper are part of the Bunya Project, an Indigenous-led participatory action research effort designed to support non-Indigenous university staff and curriculum development through partnerships with Indigenous community-controlled organizations. We conducted 24 interviews with Indigenous individuals to ascertain recommendations for health care curricula. Three themes emerged: (1) role-modeling and leadership of Indigenous-controlled health organizations; (2) specific learnings for health professionals; and (3) achieving human rights in practice. Interviews also highlighted the need for health professionals' extension beyond clinical caregiving, and staff and students' development of knowledge, skills, and actions regarding client self-determination in order to promote clients' rights across all aspects of their health care. Critical self-reflection by health professionals is a foundational individual-level skill necessary for cultural safety.

First implantable cardiac defibrillator insertions in New South Wales, 2005-2020: an analysis of linked administrative data.

OBJECTIVES: To determine the annual numbers of first ICD insertions in New South Wales during 2005-2020; to examine health outcomes for people who first received ICDs during this period. STUDY DESIGN: Retrospective cohort study; analysis of linked administrative health data. SETTING, PARTICIPANTS: All first insertions of ICDs in NSW, 2005-2020. MAIN OUTCOME MEASURES: Annual numbers of first ICD insertions, and of emergency department presentations and hospital re-admissions 30 days, 90 days, 365 days after first ICD insertions; all-cause and disease-specific mortality (to ten years after ICD insertion). RESULTS: During 2005-2020, ICDs were first inserted into 16 867 people (18.5 per 100 000 population); their mean age was 65.7 years (standard deviation, 13.5 years; 7376 aged 70 years or older, 43.7%), 13 214 were men (78.3%). The annual number of insertions increased from 791 in 2005 to 1256 in 2016; the first ICD insertion rate increased from 15.5 in 2005 to 18.9 per 100 000 population in 2010, after which the rate was stable until 2019 (19.8 per 100 000 population). Of the 16 778 people discharged alive from hospital after first ICD insertions, 54.4% presented to emergency departments within twelve months, including 1236 with cardiac arrhythmias (7.4%) and 434 with device-related problems (2.6%); 56% were re-admitted to hospital, including 1944 with cardiac arrhythmias (11.5%) and 2045 with device-related problems (12.1%). A total of 5624 people who received first ICDs during 2005-2020 (33.3%) died during follow-up (6.7 deaths per 100 person-years); the survival rate was 94.4% at one year, 76.5% at five years, and 54.2% at ten years. CONCLUSIONS: The annual number of new ICDs inserted in NSW has increased since 2005. A substantial proportion of recipients experience device-related problems that require re-admission to hospital. The potential harms of ICD insertion should be considered when assessing the likelihood of preventing fatal ventricular arrhythmia.

Pregnancy-associated gynecological cancer in New South Wales, Australia 1994-2013: A population-based historical cohort study.

INTRODUCTION: Pregnancy-associated gynecological cancer (PAGC) refers to cancers of the ovary, uterus, fallopian tube, cervix, vagina, and vulva diagnosed during pregnancy or within 12 months postpartum. We aimed to describe the incidence of, and perinatal outcomes associated with, invasive pregnancy-associated gynecological cancer. MATERIAL AND METHODS: We conducted a population-based historical cohort study using linked data from New South Wales, Australia. We included all women who gave birth between 1994 and 2013, with a follow-up period extending to September 30, 2018. Three groups were analyzed: a gestational PAGC group (women diagnosed during pregnancy), a postpartum PAGC group (women diagnosed within 1 year of giving birth), and a control group (women with control diagnosis during pregnancy or within 1 year of giving birth). We used generalized estimation equations to compare perinatal outcomes between study groups. RESULTS: There were 1 786 137 deliveries during the study period; 70 women were diagnosed with gestational PAGC and 191 with postpartum PAGC. The incidence of PAGC was 14.6/100 000 deliveries and did not change during the study period. Women with gestational PAGC (adjusted odds ratio [aAOR] 6.81, 95% confidence interval [CI] 2.97-15.62) and with postpartum PAGC (aOR 2.65, 95% CI 1.25-5.61) had significantly increased odds of a severe maternal morbidity outcome compared with the control group. Babies born to women with gestational PAGC were more likely to be born preterm (aOR 3.11, 95% CI 1.47-6.59) and were at increased odds of severe neonatal complications (aOR 3.47, 95% CI 1.45-8.31) compared with babies born to women without PAC. CONCLUSIONS: The incidence of PAGC has not increased over time perhaps reflecting, in part, the effectiveness of cervical screening and early impacts of human papillomavirus vaccination programs in Australia. The higher rate of preterm birth among the gestational PAGC group is associated with adverse outcomes in babies born to these women.

Evaluating equity across the continuum of care for maternal health services: analysis of national health surveys from 25 sub-Saharan African countries.

BACKGROUND: Ensuring access to the continuum of care for maternal, neonatal, and child health is an effective strategy for reducing maternal and child mortality. We investigated the extent of dropout, wealth-related inequalities, and drivers of inequality in the continuum of care for maternal health services in sub-Saharan Africa. METHODS: We analysed Demographic and Health Surveys (DHS) conducted between 2013 and 2019 across 25 sub-Saharan African countries. We defined the continuum of care for maternal health services as women who had received at least four ANC contacts (ANC 4 + contacts), skilled care at birth, and immediate postnatal care (PNC). We used concentration index to estimate wealth-related inequalities across the continuum of care. Multilevel logistic regression models were used to identify predictors of inequality in completing the continuum of care. RESULTS: We included data on 196,717 women with the most recent live birth. About 87% of women reported having at least one ANC contact, but only 30% of women received the recommended care package that includes ANC 4 + contacts, skilled care at birth, and PNC. The proportion of women who had completed the continuum of care ranged from 6.5% in Chad to 69.5% in Sierra Leone. Nearly 9% of women reported not having contact with the health system during pregnancy or childbirth; this ranged from 0.1% in Burundi to 34% in Chad. Disadvantaged women were more likely to have no contact with health systems and less likely to have the recommended care package than women from wealthier households. Women with higher education levels, higher exposure to mass media (radio and TV), and higher household wealth status had higher odds of completing the continuum of care. CONCLUSIONS: Persistent and increasing inequalities were observed along the continuum of care from pregnancy to the postnatal period, with socioeconomically disadvantaged women more likely to drop out of care. Improving access to and integration of services is required to improve maternal health. Initiatives and efforts to improve maternal health should prioritise and address the needs of communities and groups with low coverage of maternal health services.

Effective coverage of newborn postnatal care in Ethiopia: Measuring inequality and spatial distribution of quality-adjusted coverage.

Neonatal health is a significant global public health concern, and the first two days of life are crucial for newborn survival. Most studies on newborn postnatal care have focused on crude coverage measures, which limit the evaluation of care quality. However, evidence suggests a shift towards emphasising effective coverage, which incorporates the quality of care when measuring intervention coverage. This research aimed to assess the effective coverage of newborn postnatal care in Ethiopia while also examining its inequalities and spatial distribution. The study used secondary data from the 2016 Ethiopian Demographic and Health Survey, which was a cross-sectional community-based study. A total weighted sample of 4169 women was used for analyses. We calculated crude coverage, which is the proportion who received a postnatal check within 48 hours of birth and quality-adjusted coverage (effective coverage), which is the proportion who received a postnatal check within 48 hours of birth and reported receipt of 6 or more contents of care provided by health care providers. Concentration index and concentration curves were used to estimate the socioeconomic-related inequalities in quality-adjusted newborn postnatal care. The spatial statistic was analysed by using Arc-GIS. The crude coverage of newborn postnatal care was found to be 13.2%, while the effective coverage was 9%. High-quality postnatal care was disproportionately concentrated among the rich. A spatial variation was found in quality-adjusted coverage of newborn postnatal care across regions. The findings suggest that there is a significant gap in the coverage and quality of postnatal care for newborns across regions in Ethiopia. The low rates of coverage and effective coverage, combined with the concentration of high-quality care among the rich and the spatial variation across regions, highlight the need for targeted interventions and policies to address the inequalities in access to high-quality postnatal care for newborns.

Incidence of catastrophic health spending in Indonesia: insights from a Household Panel Study 2018-2019.

BACKGROUND: Indonesia implemented one of the world's largest single-payer national health insurance schemes (the Jaminan Kesehatan Nasional or JKN) in 2014. This study aims to assess the incidence of catastrophic health spending (CHS) and its determinants and trends between 2018 and 2019 by which time JKN enrolment coverage exceeded 80%. METHODS: This study analysed data collected from a two-round cross-sectional household survey conducted in ten provinces of Indonesia in February-April 2018 and August-October 2019. The incidence of CHS was defined as the proportion of households with out-of-pocket (OOP) health spending exceeding 10% of household consumption expenditure. Chi-squared tests were used to compare the incidences of CHS across subgroups for each household characteristic. Logistic regression models were used to investigate factors associated with incurring CHS and the trend over time. Sensitivity analyses assessing the incidence of CHS based on a higher threshold of 25% of total household expenditure were conducted. RESULTS: The overall incidence of CHS at the 10% threshold fell from 7.9% to 2018 to 4.4% in 2019. The logistic regression models showed that households with JKN membership experienced significantly lower incidence of CHS compared to households without insurance coverage in both years. The poorest households were more likely to incur CHS compared to households in other wealth quintiles. Other predictors of incurring CHS included living in rural areas and visiting private health facilities. CONCLUSIONS: This study demonstrated that the overall incidence of CHS decreased in Indonesia between 2018 and 2019. OOP payments for health care and the risk of CHS still loom high among JKN members and among the lowest income households. More needs to be done to further contain OOP payments and further research is needed to investigate whether CHS pushes households below the poverty line.

Pharmacological treatment of gastro-oesophageal reflux in children.

BACKGROUND: Gastro-oesophageal reflux (GOR) is characterised by the regurgitation of gastric contents into the oesophagus. GOR is a common presentation in infancy, both in primary and secondary care, affecting approximately 50% of infants under three months old. The natural history of GOR in infancy is generally of a self-limiting condition that improves with age, but older children and children with co-existing medical conditions can have more protracted symptoms. The distinction between gastro-oesophageal reflux disease (GORD) and GOR is debated. Current National Institute of Health and Care Excellence (NICE) guidelines define GORD as GOR causing symptoms severe enough to merit treatment. This is an update of a review first published in 2014. OBJECTIVES: To assess the effects of pharmacological treatments for GOR in infants and children. SEARCH METHODS: For this update, we searched CENTRAL, MEDLINE, Embase, and Web of Science up to 17 September 2022. We also searched for ongoing trials in clinical trials registries, contacted experts in the field, and searched the reference lists of trials and reviews for any additional trials. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared any currently-available pharmacological treatment for GOR in children with placebo or another medication. We excluded studies assessing dietary management of GORD and studies of thickened feeds. We included studies in infants and children up to 16 years old. DATA COLLECTION AND ANALYSIS: We used standard methodology expected by Cochrane. MAIN RESULTS: We included 36 RCTs involving 2251 children and infants. We were able to extract summary data from 14 RCTs; the remaining trials had insufficient data for extraction. We were unable to pool results in a meta-analysis due to methodological differences in the included studies (including heterogeneous outcomes, study populations, and study design). We present the results in two groups by age: infants up to 12 months old, and children aged 12 months to 16 years old. Infants Omeprazole versus placebo: there is no clear effect on symptoms from omeprazole. One study (30 infants; very low-certainty evidence) showed cry/fuss time in infants aged three to 12 months had altered from 246 ± 105 minutes/day at baseline (mean +/- standard deviation (SD)) to 191 ± 120 minutes/day in the omeprazole group and from 287 ± 132 minutes/day to 201 ± 100 minutes/day in the placebo group (mean difference (MD) 10 minutes/day lower (95% confidence interval (CI) -89.1 to 69.1)). The reflux index changed in the omeprazole group from 9.9 ± 5.8% in 24 hours to 1.0 ± 1.3% and in the placebo group from 7.2 ± 6.0% to 5.3 ± 4.9% in 24 hours (MD 7% lower, 95% CI -4.7 to -9.3). Omeprazole versus ranitidine: one study (76 infants; very low-certainty evidence) showed omeprazole may or may not provide symptomatic benefit equivalent to ranitidine. Symptom scores in the omeprazole group changed from 51.9 ± 5.4 to 2.4 ± 1.2, and in the ranitidine group from 47 ± 5.6 to 2.5 ± 0.6 after two weeks: MD -4.97 (95% CI -7.33 to -2.61). Esomeprazole versus placebo: esomeprazole appeared to show no additional reduction in the number of GORD symptoms compared to placebo (1 study, 52 neonates; very low-certainty evidence): both the esomeprazole group (184.7 ± 78.5 to 156.7 ± 75.1) and placebo group (183.1 ± 77.5 to 158.3 ± 75.9) improved: MD -3.2 (95% CI -4.6 to -1.8). Children Proton pump inhibitors (PPIs) at different doses may provide little to no symptomatic and endoscopic benefit. Rabeprazole given at different doses (0.5 mg/kg and 1 mg/kg) may provide similar symptom improvement (127 children in total; very low-certainty evidence). In the lower-dose group (0.5 mg/kg), symptom scores improved in both a low-weight group of children (< 15 kg) (mean -10.6 ± SD 11.13) and a high-weight group of children (> 15 kg) (mean -13.6 ± 13.1). In the higher-dose groups (1 mg/kg), scores improved in the low-weight (-9 ± 11.2) and higher-weight groups (-8.3 ± 9.2). For the higher-weight group, symptom score mean difference between the two different dosing regimens was 2.3 (95% CI -2 to 6.6), and for the lower-weight group, symptom score MD was 4.6 (95% CI -2.9 to 12). Pantoprazole: pantoprazole may or may not improve symptom scores at 0.3 mg/kg, 0.6 mg/kg, and 1.2 mg/kg pantoprazole in children aged one to five years by week eight, with no difference between 0.3 mg/kg and 1.2 mg/kg dosing (0.3 mg/kg mean -2.4 ± 1.7; 1.2 mg/kg -1.7 ± 1.2: MD 0.7 (95% CI -0.4 to 1.8)) (one study, 60 children; very low-certainty evidence). There were insufficient summary data to assess other medications. AUTHORS' CONCLUSIONS: There is very low-certainty evidence about symptom improvements and changes in pH indices for infants. There are no summary data for endoscopic changes. Medications may or may not provide a benefit (based on very low-certainty evidence) for infants whose symptoms remain bothersome, despite nonmedical interventions or parental reassurance. If a medication is required, there is no clear evidence based on summary data for omeprazole, esomeprazole (in neonates), H2antagonists, and alginates for symptom improvements (very low-certainty evidence). Further studies with longer follow-up are needed. In older children with GORD, in studies with summary data extracted, there is very low-certainty evidence that PPIs (rabeprazole and pantoprazole) may or may not improve GORD outcomes. No robust data exist for other medications. Further RCT evidence is required in all areas, including subgroups (preterm babies and children with neurodisabilities).

Methods to address selection bias in post-trial studies of legacy effects were evaluated.

OBJECTIVES: Post-trial follow-up studies have become increasingly important to investigate the long-term effectiveness of interventions after randomized controlled trials (RCTs). Legacy effects refer to intervention effects that are only observed after the trial has ended and are not the direct effects observed during the trial period. However, limited attention has been given to the potential selection bias in post-trial studies. METHODS: Using directed acyclic graphs, we illustrated potential sources of selection bias in post-trial studies of cardiovascular disease preventative interventions. We constructed scenarios where selection bias was present and undertook simulations to assess the ability of different modeling approaches to correct for this bias: no adjustment, adjustment for trial baseline covariates, adjustment for post-trial covariates and inverse probability weighting (IPW) methods. Using empirical data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial and post-trial study, we demonstrated application of different modeling approaches. RESULTS: In the presence of selection bias, modeling without adjustment always resulted in biased estimates. Modeling with adjustment and IPW methods were able to correct the selection bias. The ACCORD study also demonstrated that while the direct effects were potentially beneficial, all models attempting to address selection bias revealed larger potential legacy effects when compared to unadjusted estimates. CONCLUSION: Post-trial follow-up studies have the potential to provide valuable information for clinical practice by detecting legacy effects. However, it is important to consider and address selection bias that may arise from the post-trial study. This study highlights the importance of using an appropriate analysis method and identifying the potential bias sources to ensure that the findings are reliable and generalizable to the target population.

The Bunya Project: Protocol for a Mixed-Methods Approach to Developing a Culturally Informed Curriculum.

BACKGROUND: Indigenous peoples live across all continents, representing approximately 90 nations and cultures and 476 million people. There have long been clear statements about the rights of Indigenous peoples to self-determine services, policies, and resource allocations that affect our lives, particularly via the United Nations Declaration on the Rights of Indigenous Peoples. An area for urgent improvement is curricula that train the predominantly non-Indigenous health workforce about their responsibilities and that offer practical strategies to use when engaging with Indigenous peoples and issues. OBJECTIVE: The Bunya Project is designed to advance Indigenous community-led teaching and evaluation of the embeddedness of strategies to achieve an Indigenous Graduate Attribute in Australia. The project centers the relationships with Aboriginal community services to lead education design relating to Indigenous peoples. The project aims to articulate community recommendations for university education in allied health in the usable format of digital stories to create culturally informed andragogy, curriculum, and assessment measures for use in teaching. It also aims to understand the impact of this work on student attitudes and knowledge about Indigenous peoples' allied health needs. METHODS: Multilayered project governance was established, along with a 2-stage process using mixed methods participatory action research and critical reflection, using the reflective cycle by Gibbs. The first stage, preparing the soil, used community engagement, drew on lived experience, encouraged critical self-reflection, embodied reciprocity, and demanded working collectively. The second stage, planting the seed, requires more critical self-reflection, the development of community data through interviews and focus group discussions, the development of resources with an academic working group and community participants, the implementation of those resources with student feedback, the analysis of the feedback from students and community members, and reflection. RESULTS: The protocol for the first stage, preparing the soil, is complete. The results of the first stage are the relationships built and the trust earned and gained, and it has resulted in the development of the planting the seed protocol. As of February 2023, we have recruited 24 participants. We will analyze data shortly and expect to publish the results in 2024. CONCLUSIONS: The readiness of non-Indigenous staff to engage with Indigenous communities has not been ascertained by Universities Australia, nor can it be assured. Staff preparation and skills to support the curriculum, create a safe learning environment, and develop teaching and learning strategies to guide academics to recognize that how students learn is as important as the content students learn. This learning has broad implications and benefits for staff and students within their professional practice and for lifelong learning. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39864.

Duration of stay and rate of subsequent criminal conviction and hospitalisation for substance use among young people admitted to a short-term residential program.

INTRODUCTION: This study examined the association between program duration and rate of criminal conviction and hospitalisation for substance use up to 15 years later among young people admitted to a short-term residential program for drug and alcohol use. METHODS: Data were derived from linked administrative records of all clients referred to a modified therapeutic community for young people from January 2001 to December 2016 in New South Wales, Australia (n = 3059). Cox proportional hazards regression analyses examined the rate of conviction (separately for any offence, violent offence, non-violent offence and administrative offence) and hospitalisation for substance use, up to 15 years post-program among young people who attended treatment for 1-29 days, 30-59 days, 60-89 days and 90-120 days. RESULTS: Thirty days or more in treatment was independently associated with a lower rate of conviction for any offence and a non-violent offence, as well as hospitalisation for substance use, while 60 days or more was associated with a lower rate of conviction for a violent and administrative offence, relative to those who spent 1-29 days in the program. Additional months in the program were also associated with reduced rates of conviction and hospitalisation, although 90-120 days appeared to confer no additional benefits than 60-89 days. DISCUSSION AND CONCLUSIONS: At least 60 days may be the minimum duration needed for short-term, therapeutic community programs to reduce the risk of conviction across all crime types and hospitalisation for substance use.

The relationship between biochemical recurrence and number of lymph nodes removed during surgery for localized prostate cancer.

PURPOSE: To assess whether completeness of pelvic lymph node dissection (PLND) as measured by lymph node yield reduces biochemical recurrence (BCR) in men undergoing radical prostatectomy (RP) for prostate cancer (PCa), stratified according to Briganti nomogram-derived risk (≥5% vs. < 5%) of lymph node invasion (LNI). METHODS: Retrospective study of 3724 men who underwent RP between January 1995 and January 2015 from our prospectively collected institutional database. All men included had minimum five years follow-up and were not given androgen deprivation therapy or radiotherapy prior to BCR. Primary endpoint was time to BCR as defined by PSA > 0.2ng/ml. Patients were analysed according to Briganti Nomogram derived risk of 'low-risk' (< 5%) vs. 'high-risk' (≥ 5%). Extent of PLND was analysed using number of nodes yielded at dissection as a continuous variable as well as a categorical variable: Group 1 (limited, 1-4 nodes), Group 2 (intermediate, 5-8 nodes) and Group 3(extensive, ≥9 nodes). RESULTS: Median follow-up in the overall cohort was 79.7 months and 65% of the total cohort underwent PLND. There were 2402 patients with Briganti risk of LNI < 5% and 1322 with a Briganti risk of LNI ≥5%. At multivariate analysis, only PSA (HR1.01, p < 0.001), extracapsular extension at RP (HR 1.86, p < 0.001), positive surgical margin (HR 1.61, p < 0.001) and positive lymph node on pathology (HR 1.52, p = 0.02) were independently associated with BCR. In the high-risk group, increased nodal yield at PLND was associated with reduction in risk of BCR (HR 0.97, 95%CI 0.95-1.00 p = 0.05, Cochran Mantel Haenszel test, p < 0.05: respectively). In the low-risk group increased number of nodes at PLND did not reduce risk of BCR. CONCLUSIONS: In this study of extent of PLND at RP, higher nodal yield did not reduce risk of BCR in low-risk men (Briganti risk < 5%), however there was a weak benefit in terms of reduced long-term risk of BCR in high-risk men (Briganti risk ≥5%).

Regular high-frequency whole blood donation and risk of cardiovascular disease in middle-aged and older blood donors in Australia.

BACKGROUND: Previous mixed findings on the associations between whole blood (WB) donation and risk of cardiovascular diseases (CVD) may in part reflect inadequate adjustment for the "healthy donor effect" (HDE). METHODS: We used the Sax Institute's 45 and Up Study linked with blood donation history and other health-related databases to examine the association between regular, high-frequency WB donation and the risk of CVD. To mitigate the impact of HDE, we used a "5-years qualification period," in which donors must donate at least 1 WB donation in the 1st and 5th year of "qualification period." We then compared the risk of CVD in the years following the "qualification period" between the regular high-frequency WB donors (≥2 WB donation in each qualification year) and others using Cox proportional-hazards models. Analyses were adjusted for potential confounders, such as sociodemographic, lifestyle, and health-related variables, and results are reported separately for male and female donors. RESULTS: A total of 2736 male and 2917 female donors were included in the analyses. The median years of follow-up per donor was 5.84 years (Q1-Q3, 5.47-6.23). The rate of CVD hospitalization was 11.20 and 4.50 per 1000 person-years for males and females, respectively. In fully adjusted models, the risk (hazard ratio) of CVD in regular high-frequency donors compared to other donors was 0.93 (95% Confidence Interval (CI), 0.68-1.29) for males and 0.79 (95% CI, 0.49-1.28) for females. CONCLUSIONS: We did not observe a statistically significant reduction of CVD risk in regular, high-frequency WB donors when adjusted for potential confounders.

The benefits and burden of health financing in Indonesia: analyses of nationally representative cross-sectional data.

BACKGROUND: Indonesia has committed to deliver universal health coverage by 2024. Reforming the country's health-financing system is key to achieving this commitment. We aimed to evaluate how the benefits and burden of health financing are distributed across income groups and the extent to which Indonesia has achieved equity in the funding and delivery of health care after financing reforms. METHODS: We conducted benefit incidence analyses (BIA) and financing incidence analyses (FIA) using cross-sectional nationally representative data from several datasets. Two waves (Feb 1 to April 30, 2018, and Aug 1 to Oct 31, 2019) of the Equity and Health Care Financing in Indonesia (ENHANCE) study household survey involving 7500 households from ten of the 34 provinces in Indonesia were used to obtain health and socioeconomic status data for the BIA. Two waves (2018 and 2019) of the National Socioeconomic Survey (SUSENAS), the most recent wave (2014) of the Indonesian Family Life Survey, and the 2017 and 2018 National Health Accounts were used to obtain data for the FIA. In the BIA, we calculated a concentration index to assess the distribution of health-care benefits (-1·0 [pro-poor] to 1·0 [pro-rich]), considering potential differences in health-care need. In the FIA, we evaluated the equity of health-financing contributions by socioeconomic quintiles by calculating the Kakwani index to assess the relative progressivity of each financing source. Both the BIA and FIA compared results from early 2018 (baseline) with results from late 2019. FINDINGS: There were 31 864 participants in the ENHANCE survey in 2018 compared with 31 215 in 2019. Women constituted 50·5% and men constituted 49·5% of the total participants for each year. SUSENAS had 1 131 825 participants in 2018 compared with 1 204 466 in 2019. Women constituted 49·9% of the participants for each year, whereas men constituted 51·1%. The distribution of health-care benefits in the public sector was marginally pro-poor; people with low income received a greater proportion of benefits from health services than people with high income between 2018 (concentration index -0·008, 95% CI -0·075 to 0·059) and 2019 (-0·060, -0·139 to 0·019). The benefit incidence in the private health sector was significantly pro-rich in 2018 (0·134, 0·065 to 0·203, p=0·0010) and 2019 (0·190, -0·192 to 0·572, p=0·0070). Health-financing incidence changed from being moderately progressive in 2018 (Kakwani index 0·034, 95% CI 0·030 to 0·038) to mildly regressive in 2019 (-0·030, -0·034 to -0·025). INTERPRETATION: Although Indonesia has made substantial progress in expanding health-care coverage, a lot remains to be done to improve equity in financing and spending. Improving comprehensiveness of benefits will reduce out-of-pocket spending and allocating more funding to primary care would improve access to health-care services for people with low income. FUNDING: UK Health Systems Research Initiative, UK Department of International Development, UK Economic and Social Research Council, UK Medical Research Council, and Wellcome Trust.

Pregnancy associated cancer, timing of birth and clinical decision making-a NSW data linkage study.

BACKGROUND: The incidence of pregnancy-associated cancer (PAC), comprising cancer diagnosed during pregnancy or within one year postpartum, is increasing. We investigated the obstetric management and outcomes of women with PAC and their babies. METHODS: A population-based observational study of all women who gave birth between 1994 and 2013 in New South Wales, Australia. Women were stratified into three groups: those diagnosed during pregnancy (gestational cancer group), those diagnosed within one year of giving birth (postpartum cancer group), and a no-PAC group. Generalized estimating equations were used to examine the association between PAC and adverse maternal and neonatal outcomes. RESULTS: One million seven hundred eighty-eight thousand four hundred fifty-onepregnancies were included-601 women (614 babies) were in the gestational cancer group, 1772 women (1816 babies) in the postpartum cancer group, and 1,786,078 women (1,813,292 babies) in the no-PAC group. The overall crude incidence of PAC was 132.7/100,000 women giving birth. The incidence of PAC increased significantly over the twenty-year study period from 93.5/100,000 in 1994 to 162.5/100,000 in 2013 (2.7% increase per year, 95% CI 1.9 - 3.4%, p-value < 0.001). This increase was independent of maternal age. The odds of serious maternal complications (such as acute abdomen, acute renal failure, and hysterectomy) were significantly higher in the gestational cancer group (adjusted odds ratio (AOR) 5.07, 95% CI 3.72 - 6.90) and the postpartum cancer group (AOR 1.55, 95% CI 1.16 - 2.09). There was no increased risk of perinatal mortality in babies born to women with PAC. However, babies of women with gestational cancer (AOR 8.96, 95% CI 6.96 - 11.53) or postpartum cancer (AOR 1.36, 95% CI 1.05 - 1.81) were more likely to be planned preterm birth. Furthermore, babies of women with gestational cancer had increased odds of a severe neonatal adverse outcome (AOR 3.13, 95% CI 2.52 - 4.35). CONCLUSION: Women with PAC are more likely to have serious maternal complications. While their babies are not at increased risk of perinatal mortality, they are more likely to experience poorer perinatal outcomes associated with preterm birth. The higher rate of birth intervention among women with gestational cancers reflects the complexity of clinical decision-making in this context.