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.

Watch me grow integrated (WMG-I): protocol for a cluster randomised controlled trial of a web-based surveillance approach for developmental screening in primary care settings.

INTRODUCTION: The increasing prevalence of developmental disorders in early childhood poses a significant global health burden. Early detection of developmental problems is vital to ensure timely access to early intervention, and universal developmental surveillance is recommended best practice for identifying issues. Despite this, there is currently considerable variation in developmental surveillance and screening between Australian states and territories and low rates of developmental screening uptake by parents. This study aims to evaluate an innovative web-based developmental surveillance programme and a sustainable approach to referral and care pathways, linking primary care general practice (GP) services that fall under federal policy responsibility and state government-funded child health services. METHODS AND ANALYSIS: The proposed study describes a longitudinal cluster randomised controlled trial (c-RCT) comparing a 'Watch Me Grow Integrated' (WMG-I) approach for developmental screening, to Surveillance as Usual (SaU) in GPs. Forty practices will be recruited across New South Wales and Queensland, and randomly allocated into either the (1) WMG-I or (2) SaU group. A cohort of 2000 children will be recruited during their 18-month vaccination visit or opportunistic visit to GP. At the end of the c-RCT, a qualitative study using focus groups/interviews will evaluate parent and practitioner views of the WMG-I programme and inform national and state policy recommendations. ETHICS AND DISSEMINATION: The South Western Sydney Local Health District (2020/ETH01625), UNSW Sydney (2020/ETH01625) and University of Queensland (2021/HE000667) Human Research Ethics Committees independently reviewed and approved this study. Findings will be reported to the funding bodies, study institutes and partners; families and peer-reviewed conferences/publications. TRIAL REGISTRATION NUMBER: ANZCTR12621000680864.

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.

A cardiovascular disease policy model: part 2-preparing for economic evaluation and to assess health inequalities.

OBJECTIVES: This is the second of the two papers introducing a cardiovascular disease (CVD) policy model. The first paper described the structure and statistical underpinning of the state-transition model, demonstrating how life expectancy estimates are generated for individuals defined by ASSIGN risk factors. This second paper describes how the model is prepared to undertake economic evaluation. DESIGN: To generate quality-adjusted life expectancy (QALE), the Scottish Health Survey was used to estimate background morbidity (health utilities) and the impact of CVD events (utility decrements). The SF-6D algorithm generated utilities and decrements were modelled using ordinary least squares (OLS). To generate lifetime hospital costs, the Scottish Heart Health Extended Cohort (SHHEC) was linked to the Scottish morbidity and death records (SMR) to cost each continuous inpatient stay (CIS). OLS and restricted cubic splines estimated annual costs before and after each of the first four events. A Kaplan-Meier sample average (KMSA) estimator was then used to weight expected health-related quality of life and costs by the probability of survival. RESULTS: The policy model predicts the change in QALE and lifetime hospital costs as a result of an intervention(s) modifying risk factors. Cost-effectiveness analysis and a full uncertainty analysis can be undertaken, including probabilistic sensitivity analysis. Notably, the impacts according to socioeconomic deprivation status can be made. CONCLUSIONS: The policy model can conduct cost-effectiveness analysis and decision analysis to inform approaches to primary prevention, including individually targeted and population interventions, and to assess impacts on health inequalities.

A cardiovascular disease policy model that predicts life expectancy taking into account socioeconomic deprivation.

OBJECTIVES: A policy model is a model that can evaluate the effectiveness and cost-effectiveness of interventions and inform policy decisions. In this study, we introduce a cardiovascular disease (CVD) policy model which can be used to model remaining life expectancy including a measure of socioeconomic deprivation as an independent risk factor for CVD. DESIGN: A state transition model was developed using the Scottish Heart Health Extended Cohort (SHHEC) linked to Scottish morbidity and death records. Individuals start in a CVD-free state and can transit to three CVD event states plus a non-CVD death state. Individuals who have a non-fatal first event are then followed up until death. Taking a competing risk approach, the cause-specific hazards of a first event are modelled using parametric survival analysis. Survival following a first non-fatal event is also modelled parametrically. We assessed discrimination, validation and calibration of our model. RESULTS: Our model achieved a good level of discrimination in each component (c-statistics for men (women)-non-fatal coronary heart disease (CHD): 0.70 (0.74), non-fatal cerebrovascular disease (CBVD): 0.73 (0.76), fatal CVD: 0.77 (0.80), fatal non-CVD: 0.74 (0.72), survival after non-fatal CHD: 0.68 (0.67) and survival after non-fatal CBVD: 0.65 (0.66)). In general, our model predictions were comparable with observed event rates for a Scottish randomised statin trial population which has an overlapping follow-up period with SHHEC. After applying a calibration factor, our predictions of life expectancy closely match those published in recent national life tables. CONCLUSIONS: Our model can be used to estimate the impact of primary prevention interventions on life expectancy and can assess the impact of interventions on inequalities.

Investing in health: is social housing value for money? A cost-utility analysis.

BACKGROUND: There is a healthy public policy agenda investigating the health impacts of improving living conditions. However, there are few economic evaluations, to date, assessing value for money. We conducted the first cost-effectiveness analysis of a nationwide intervention transferring social and private tenants to new-build social housing, in Scotland. METHODS: A quasi-experimental prospective study was undertaken involving 205 intervention households and 246 comparison households, over 2 years. A cost-utility analysis assessed the average cost per change in health utility (a single score summarising overall health-related quality of life), generated via the SF-6D algorithm. Construction costs for new builds were included. Analysis was conducted for all households, and by family, adult and elderly households; with estimates adjusted for baseline confounders. Outcomes were annuitised and discounted at 3.5%. RESULTS: The average discounted cost was £18, 708 per household, at a national programme cost of £ 28.4 million. The average change in health utility scores in the intervention group attributable to the intervention were +0.001 for all households, +0.001 for family households, -0.04 for adult households and -0.03 for elderly households. All estimates were statistically insignificant. CONCLUSIONS: At face value, the interventions were not value for money in health terms. However, because the policy rationale was the amenity provision of housing for disadvantaged groups, impacts extend beyond health and may be fully realised over the long term. Before making general value-for-money inferences, economic evaluation should attempt to estimate the full social value of interventions, model long-term impacts and explicitly incorporate equity considerations.

Enhancements to the JET poloidally scanning vacuum ultraviolet∕visible spectrometers.

Enhancements to the JET poloidally scanning spectrometers are presented, which will aid the exploitation of the recently installed ITER-like wall in JET. They include the installation of visible filter∕photomultiplier tube assemblies and spectrometers and the replacement of large rotating mirrors in the JET vacuum with small oscillating mirrors outside. The upgrade has resulted in a more robust and reliable diagnostic than before, which is described. Drifts in the mirror angle reconstructed from quadrature encoder signals are found, a reference signal being required. The use of the small scanning mirrors necessitated the inclusion of focusing mirrors to maintain throughput into the vacuum ultraviolet spectrometers. The mirror design has taken account of the extreme sensitivity of the focusing to the grazing angle of incidence, an aspect of importance in the design of grazing incidence focusing components on future machines, such as ITER. The visible system has been absolutely calibrated using an in-vessel light source.

ITER-relevant calibration technique for soft x-ray spectrometer.

The ITER-oriented JET research program brings new requirements for the low-Z impurity monitoring, in particular for the Be­the future main wall component of JET and ITER. Monitoring based on Bragg spectroscopy requires an absolute sensitivity calibration, which is challenging for large tokamaks. This paper describes both "component-by-component" and "continua" calibration methods used for the Be IV channel (75.9 Å) of the Bragg rotor spectrometer deployed on JET. The calibration techniques presented here rely on multiorder reflectivity calculations and measurements of continuum radiation emitted from helium plasmas. These offer excellent conditions for the absolute photon flux calibration due to their low level of impurities. It was found that the component-by-component method gives results that are four times higher than those obtained by means of the continua method. A better understanding of this discrepancy requires further investigations.

Comparison of mass and targeted screening strategies for cardiovascular risk: simulation of the effectiveness, cost-effectiveness and coverage using a cross-sectional survey of 3921 people.

BACKGROUND: Cardiovascular primary prevention should be targeted at those with the highest global risk. However, it is unclear how best to identify such individuals from the general population. The aim of this study was to compare mass and targeted screening strategies in terms of effectiveness, cost effectiveness and coverage. METHODS: The Scottish Health Survey provided cross-sectional data on 3921 asymptomatic members of the general population aged 40-74 years. We undertook simulation models of five screening strategies: mass screening, targeted screening of deprived communities, targeted screening of family members and combinations of the latter two. RESULTS: To identify one individual at high risk of premature cardiovascular disease using mass screening required 16.0 people to be screened at a cost of pound370. Screening deprived communities targeted 17% of the general population but identified 45% of those at high risk, and identified one high-risk individual for every 6.1 people screened at a cost of pound141. Screening family members targeted 28% of the general population but identified 61% of those at high risk, and identified one high-risk individual for every 7.4 people screened at a cost of pound170. Combining both approaches enabled 84% of high risk individuals to be identified by screening only 41% of the population. Extending targeted to mass screening identified only one additional high-risk person for every 58.8 screened at a cost of pound1358. CONCLUSIONS: Targeted screening strategies are less costly than mass screening, and can identify up to 84% of high-risk individuals. The additional resources required for mass screening may not be justified.

Comparison of olestra absorption in guinea pigs with normal and compromised gastrointestinal tracts.

Female guinea pigs (12/group) were given a single dose of [14C]olestra by gavage after consuming either 3% poligeenan in tap water (Compromised group) or just tap water (Normal group) for 5 weeks. A Sentinel group (N = 2) was given 3% poligeenan for 5 weeks. Ten sentinel animals were killed 1 day before and 10 1 day after the other animals were dosed with [14C]olestra and their gastrointestinal tracts were examined by histology. The Compromised and Normal animals were endoscoped just before dosing with [14C]olestra. Urine and feces were collected continuously and CO2 was collected for 7 days after dosing. The samples were analyzed for 14C and urine was also analyzed for [14C]sucrose. Animals (3/group) were killed 1, 3, 7, and 21 days after dosing, and tissues were collected and assayed for 14C. Tissue lipids were extracted, fractionated by high-pressure liquid chromatography, and analyzed for [14C]olestra by liquid scintillation. Animals fed poligeenan showed mucosal edema, congestion, ulceration, and fibrin deposition within the distal colon and rectum. Histology revealed inflammation, epithelial degeneration, and multifocal ulceration of the cecum, distal colon, and rectum. The gastrointestinal mucosae of nonpoligeenan fed animals were normal. No [14C]olestra was detected in liver lipids and no [14C]sucrose was found in the urine for any animal in the Normal or Compromised groups, indicating that intact olestra was not absorbed. The amount, distribution, and elimination of absorbed 14C did not differ between guinea pigs with normal and compromised gastrointestinal tracts. The poligeenan-treated animals displayed mucosal damage similar to that seen in human inflammatory bowel diseases; therefore, these results suggest that patients with inflammatory bowel conditions will not absorb olestra to any greater extent than normal healthy people.

Olestra, a nonabsorbed, noncaloric replacement for dietary fat: a review.

Olestra has been shown to be safe for its intended use by extensive testing in animals and in humans. It is not digested or absorbed and has no effect on the structure or physiology of the GI tract, the only organ of the body that it contacts. Olestra can interfere with the absorption of other lipophilic substances from the GI tract. The interference occurs because a portion of those molecules that are sufficiently lipophilic partition into the nonabsorbed olestra and is carried out of the body. Whether olestra will interfere with the absorption of a specific molecule can be predicted from the octanol-water partition coefficient of the molecule, a parameter that can be measured or calculated from a knowledge of the structure of the molecule. Olestra does not affect the absorption or efficacy of oral drugs because, in general, they are not sufficiently lipophilic to partition into the olestra. Olestra does not affect the absorption of water-soluble micronutrients or the absorption and utilization of macronutrients. Olestra can reduce the absorption of the fat-soluble vitamins when olestra foods and the vitamins are coingested. These effects can be offset by adding specific amounts of the vitamins to foods made with olestra. Other than the carotenoids and vitamins A and E, olestra does not affect the absorption of potentially beneficial components of fruits and vegetables. The effects on the vitamins can be offset by adding the vitamins to olestra foods. The reduction in the absorption of carotenoids will be less than 6-10% when olestra snacks are eaten under free-living dietary patterns. Any effect this reduction has on vitamin A status can be offset by addition of vitamin A to the foods. The absorption of flavonoids, polyphenols, and most other phytochemicals in fruits and vegetables, which have been shown to provide beneficial health effects, will not be affected by olestra because they are not sufficiently lipophilic. Individuals consuming large quantities of olestra may experience mild or moderate common GI symptoms such as loose or soft stools, gas, or nausea, symptoms similar to those experienced with certain other foods or changed dietary habits. When olestra snack foods are eaten under free-living dietary patterns, the symptoms are not different from those experienced when eating full-fat snack products, in either incidence or severity. When they are experienced, the symptoms resolve in 1-2 days, but may recur. They do not worsen with continued or increased olestra consumption and pose no health risk to the consumer. Olestra products will carry an information label alerting consumers to the possibility of GI symptoms. Olestra foods provide an additional option to those individuals who want or need to lower their total energy intake and body weight. These individuals will find it easier to change dietary habits and to maintain healthful nutritional practices when they use olestra foods. For those who want or need to reduce fat intake but not lose weight, olestra foods can reduce fat intake without affecting energy. Because olestra foods have taste and other organoleptic properties that are similar to those of full-fat foods, individuals will find it easier to switch to low-fat diets.

Assessment of the nutritional effects of olestra, a nonabsorbed fat replacement: introduction and overview.

Olestra is a mixture of polyesters formed from sucrose and fatty acids derived from edible fats and oils. It is not absorbed or digested and can serve as a zero-calorie replacement for dietary fat. Because olestra is lipophilic and not absorbed, it has the potential to interfere with the absorption of other dietary components, especially lipophilic ones, when it is in the digestive tract with those components. A series of studies were conducted in the domestic pig and in healthy adult humans to define the nature and extent of olestra's effect on fat-soluble vitamins, selected water-soluble micronutrients, and macronutrients, and to demonstrate that the effects of olestra on the absorption of fat-soluble vitamins can be offset by adding extra amounts of the affected vitamins to olestra foods. Before conducting the human and pig studies, the intake of olestra from the consumption of snack foods made with olestra was estimated for various subgroups. The potential for olestra to affect the absorption of nonessential but potentially beneficial dietary phytochemicals was also assessed. In addition, an assessment of how consumption patterns influence the effect of olestra on the absorption of the highly lipophilic carotenoids was made. Finally, the results from the pig and human studies were used to assess the potential for olestra to affect the nutritional status of subgroups of the population who have particularly high nutrient needs or unique dietary patterns that may lead to large olestra-to-nutrient intake ratios.

Assessment of the nutritional effects of olestra, a nonabsorbed fat replacement: summary.

Olestra is a zero-calorie fat replacement intended to replace 100% of the fat used in the preparation of savory snacks. Olestra can affect the absorption of other dietary components, especially highly lipophilic ones, when ingested at the same time. The potential effects of olestra on the absorption of essential fat-soluble and water-soluble dietary components have been investigated in pigs and in humans. In these studies, subjects were fed daily amounts of olestra up to 10 times the estimated mean intake from savory snacks and the olestra was eaten each day of the studies. In real life, snacks are eaten on average five times in a 14-d period. Olestra did not affect the availability of water-soluble micronutrients or the absorption and utilization of macronutrients. Olestra reduced the absorption of fat-soluble vitamins A, D, E and K; however, the effects can be offset by adding specified amounts of the vitamins to olestra foods. Olestra also reduced the absorption of carotenoids; analysis of dietary patterns showed that in real life the reduction will likely be <10%. Any effect on vitamin A stores caused by a reduction in carotenoid uptake is offset by the addition of vitamin A to olestra foods. Because of the olestra-to-nutrient ratios fed and the nutritional requirements of the test subjects, the effects of olestra on nutritional status of subgroups of the population are unlikely to be different than those measured in the studies. An analysis of lipophilicity showed that olestra is unlikely to significantly affect the uptake of potentially beneficial phytochemicals from fruits and vegetables. Some people eating large amounts of olestra snacks may experience common GI symptoms such as stomach discomfort or changes in stool consistency, similar to symptoms accompanying other dietary changes. These symptoms present no health risks.

Disposition of ingested olestra in weanling mini-pigs.

The disposition of ingested olestra in Hanford mini-pigs was examined by following a single oral gavage dose of radiolabelled (U-14C-sucrose) olestra Eight dosed animal (four/sex) and one undosed animal were killed 1, 3 and 7 days after dosing, and tissues were collected and counted. Urine and faeces were collected continuously and counted. Tissue lipids were extracted and analysed for intact radiolabelled olestra by size exclusion chromatography. Sucrose will be excreted in urine if olestra is absorbed and metabolized. Mean recovery of radiolabel was 96.6% of the administered dose. Of the recovered radiolabel, more than 99.4%, on average, was not absorbed and found in faeces, or cage and animal wash solutions. The absorbed radiolabel (0.6%), was distributed across the carcass, all tissues and blood, or excreted in urine. This radiolabel primarily came from the metabolism of glucose and fructose resulting from the hydrolysis of the trace levels of penta- and lower sucrose esters present in the test material. No radiolabel was found in the olestra-containing fraction of liver lipids, the primary measure of absorbed and non-metabolized olestra, at a detection limit of 0.0002% of dose. A conservative estimate of the amount of 14C-sucrose excreted in the urine was 0.0012%. The total absorption of intact olestra was thus less than 0.0014% of the dose, the sum of the two measures. These results indicate that intact olestra is essentially not absorbed by the weanling mini-pig, an animal with a young developing gastrointestinal tract similar to that of young children (2-5 yr).

Disposition of ingested olestra in the Fischer 344 rat.

Four studies were conducted in the Fischer 344 rat to determine the disposition of orally gavaged olestra. Twenty-four rats were used for each study. Three olestra samples, differing in the degree of saturation of the fatty acid chains, were tested; one sample was heated to simulate olestra's intended use in preparing fried foods. In addition, a sucrose polyester (SPE) sample containing 28% short-chain penta- and lower polyesters was tested. All test samples were uniformly labeled with 14C in the sucrose moiety. Urine, feces, and CO2 were continuously collected and counted. Urine also was analyzed for [14C]sucrose by HPLC. If olestra were absorbed and systemically metabolized, [14C]sucrose would be excreted in the urine. Rats were killed 1, 3, 7, and 21 days after dosing, and tissues were collected and counted. Tissue lipids were extracted and analyzed for intact olestra or SPE by HPLC. Less than 0.15% of the dose of 14C was absorbed from the olestra samples, and about 1.3% from the SPE sample. The disposition of the absorbed radiolabel suggested that its source was glucose and fructose resulting from the intestinal hydrolysis of short-chain penta- and lower sucrose polyesters. For rats dosed with olestra, < 8 x 10(-4)% of the dose of radiolabel was recovered in the olestra-containing fraction of lipids extracted from liver, the target organ for absorbed olestra, and no [14C]sucrose was found in urine, indications that olestra essentially was not absorbed. Heating olestra did not change this result.(ABSTRACT TRUNCATED AT 250 WORDS)

Diaper dermatitis: frequency and severity among a general infant population.

The frequency and severity of diaper dermatitis was measured among a midwestern suburban population of 1089 infants ranging in age from 1 to 20 months. No diagnosis of specific etiology was made. Fecal samples were collected and analyzed for Candida albicans, and information on family characteristics, infant diet, general health, history of rash, and diapering habits and practices was collected by questionnaire. The distribution of the severity of observed diaper rash can be described as a logarithmic-normal function, implying several multiplicative causative factors. Within the total severity range, there appear to be three subcategories of diaper rash, differing in some manner, perhaps reflecting different etiologies. The frequency of observed diaper rash was a function of the maturity of the infant, reaching a maximum around 9 to 12 months of age. The prevalence of severe rash correlated with the presence and level of fecal C. albicans. Infants diapered exclusively in disposable diapers showed less rash (P less than 0.001) than those diapered exclusively or sometimes in cloth diapers.

The effects of wearing diapers on skin.

Wearing dry and wet cloth and disposable diaper materials has certain effects on the degree of skin wetness. These, in turn, affect the coefficient of skin friction, the skin's susceptibility to abrasion damage, its permeability, and its support of microbial growth. These effects were explored using an adult model wearing forearm patches. The adult model was validated by comparisons of skin wetness and friction values for infants and adults determined under similar conditions. Skin wetness was proportional to diaper wetness. With increased skin wetness, there were increased coefficients of friction and increased abrasion damage, skin permeability, and microbial growth. Cloth diaper material produced wetter skin than did disposable diaper material at equivalent loadings.