Effect of a coaching intervention to enhance physical activity and prevent falls in community-dwelling people aged 60+ years: a cluster randomised controlled trial.

OBJECTIVES: To evaluate the effect of a coaching intervention compared with control on physical activity and falls rate at 12 months in community-dwelling people aged 60+ years. DESIGN: Cluster randomised controlled trial. SETTING: Community-dwelling older people. PARTICIPANTS: 72 clusters (605 participants): 37 clusters (290 participants) randomised to the intervention and 35 (315 participants) to control. INTERVENTION: Intervention group received written information, fall risk assessment and prevention advice by a physiotherapist, activity tracker and telephone-based coaching from a physiotherapist focused on safe physical activity. Control group received written information and telephone-based dietary coaching. Both groups received up to 19 sessions of telephone coaching over 12 months. OUTCOMES: The co-primary outcomes were device-measured physical activity expressed in counts per minute at 12 months and falls rate over 12 months. Secondary outcomes included the proportion of fallers, device-measured daily steps and moderate-to-vigorous physical activity (MVPA), self-reported hours per week of physical activity, body mass index, eating habits, goal attainment, mobility-related confidence, quality of life, fear of falling, risk-taking behaviour, mood, well-being and disability. RESULTS: The mean age of participants was 74 (SD 8) years, and 70% (n=425) were women. There was no significant effect of the intervention on device-measured physical activity counts per minute (mean difference 5 counts/min/day, 95% CI -21 to 31), or falls at 12 months (0.71 falls/person/year in intervention group and 0.87 falls/person/year in control group; incidence rate ratio 0.86, 95% CI 0.65 to 1.14). The intervention had a positive significant effect on device-measured daily steps and MVPA, and self-reported hours per week of walking, well-being, quality of life, and disability. No significant between-group differences were identified in other secondary outcomes. CONCLUSION: A physical activity and fall prevention programme including fall risk assessment and prevention advice, plus telephone-based health coaching, did not lead to significant differences in physical activity counts per minute or falls rate at 12 months. However, this programme improved other physical activity measures (ie, daily steps, MVPA, hours per week of walking), overall well-being, quality of life and disability. TRIAL REGISTRATION NUMBER: ACTRN12615001190594.

Evaluating a shared care pathway intervention for people receiving chemotherapy to reduce post-treatment unplanned hospital presentations: a randomised controlled trial.

PURPOSE: The aim of this randomised controlled trial (RCT) was to explore whether a community nursing intervention for outpatients receiving systemic therapy reduced unplanned hospital presentations and improved physical and psychosocial health outcomes over the first three cycles of treatment compared to a control group receiving standard care. METHODS: The number of and reasons for unplanned presentations were obtained for 170 intervention and 176 control group adult patients with solid tumours starting outpatient chemotherapy. Poisson regression was used to compare the number of presentations between the intervention and control groups. Patients self-completed the Hospital Anxiety and Depression Scale, the Cancer Behavior Inventory and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) at the start of the first four cycles. Linear regression techniques were used to compare quality of life outcomes. RESULTS: The reduction in unplanned presentations in the intervention group relative to the control group was 12% (95% CI, - 25%, 37%; P = 0.48). At the start of cycle 4, there was no difference in anxiety (difference = 0.47 (95% CI, - 0.28, 1.22; P = 0.22)), depression (difference = 0.57 (95% CI, - 0.18, 1.31; P = 0.13)) or EORTC QLQ-C30 summary score (difference = 0.16 (95% CI, - 2.67, 3.00; P = 0.91)). Scores for self-efficacy as measured by the Cancer Behavior Inventory were higher in the intervention group (difference = 4.3 (95% CI, 0.7, 7.9; P = 0.02)). CONCLUSION: This RCT did not demonstrate a benefit in reducing unplanned presentations to hospital. The trial identified improved cancer-based self-efficacy in patients receiving the intervention. TRIAL REGISTRATION: Registered at Australian and New Zealand Clinical Trials Registry: ACTRN12614001113640, registered 21/10/2014.

Investigating community-based care service factors delaying residential care home admission of community dwelling older adults and cost consequence.

OBJECTIVES: To examine factors contributing to delaying care home admission; and compare the rates of care home admission and cost consequence between two government subsidised programmes, Veterans' Affairs Community Nursing (VCN) and Home Care Package (HCP). METHODS: Our national, population-based retrospective cohort study and cost analysis used existing, de-identified veterans' claims databases (2010-19) and the Registry of Senior Australians Historical Cohort (2010-17), plus aggregate programme expenditure data. This involved 21,636 VCN clients (20,980 aged 65-100 years), and an age- and sex-matched HCP cohort (N = 20,980). RESULTS: Service factors associated with lower risk of care home admission in the VCN cohort were periodic (versus continuous) service delivery (HR 0.27 [95%CI, 0.24-0.31] for ≤18 months; HR 0.89 [95%CI, 0.84-0.95] for >18 months), and majority care delivered by registered nurses (versus personal care workers) (HR 0.86 [95%CI, 0.75-0.99] for ≤18 months; HR 0.91 [95%CI, 0.85-0.98] for >18 months). In the matched cohorts, the time to care home admission for VCN clients (median 28 months, IQR 14-42) was higher than for HCP clients (14, IQR 6-27). Within 5 years of service access, 57.6% (95%CI, 56.9-58.4) of HCP clients and 26.6% (95%CI, 26.0-27.2) of VCN clients had care home admission. The estimated cost saving for VCN recipients compared to HCP recipients over 5 years for relevant government providers was over A$1 billion. CONCLUSIONS: Compared to an HCP model, individuals receiving VCN services remained at home longer, with potentially significant cost savings. This new understanding suggests timely opportunity for many countries' efforts to enhance community-based care services.

Interaction effects of multimorbidity and frailty on adverse health outcomes in elderly hospitalised patients.

We quantified the interaction of multimorbidity and frailty and their impact on adverse health outcomes in the hospital setting. Using aretrospective cohort study of persons aged ≥ 75 years, admitted to hospital during 2010-2012 in New South Wales, Australia, and linked with mortality data, we constructed multimorbidity, frailty risk and outcomes: prolonged length of stay (LOS), 30-day mortality and 30-day unplanned readmissions. Relative risks (RR) of outcomes were obtained using Poisson models with random intercept for hospital. Among 257,535 elderly inpatients, 33.6% had multimorbidity and elevated frailty risk, 14.7% had multimorbidity only, 19.9% had elevated frailty risk only and 31.8% had neither. Additive interactions were present for all outcomes, with a further multiplicative interaction for mortality and LOS. Mortality risk was 4.2 (95% CI 4.1-4.4), prolonged LOS 3.3 (95% CI 3.3-3.4) and readmission 1.8 (95% CI 1.7-1.9) times higher in patients with both factors present compared with patients with neither. In conclusion, multimorbidity and frailty coexist in older hospitalized patients and interact to increase the risk of adverse outcomes beyond the sum of their individual effects. Their joint effect should be considered in health outcomes research and when administering hospital resources.

Patient perceptions of a community-based intervention designed to provide support post administration of anti-cancer systemic treatments: A qualitative evaluation.

PURPOSE: This paper reports on patient participant experiences of a larger randomised controlled trial evaluating a shared-care pathway intervention designed to support outpatients at home during their first three cycles of systemic anti-cancer therapies delivered in two large tertiary hospitals in Sydney, Australia. This qualitative study explores the perspectives of patient participants who received the intervention, which involved targeted home visits by community nurses post treatment administration. METHODS: A qualitative inductive thematic analysis was used to examine data from semi-structured interviews with patients who received the intervention. RESULTS: Twenty-five patient participants were interviewed. We identified four themes: Stepping into the unknown; Impact of availability of health and social care support; Building confidence to manage self-care; Uncertainty, frailty and co-morbidities. Targeted support at home is seen to be effective and welcomed by patients as early stages of each treatment cycle can be extremely challenging, particularly for those who are elderly, frail or with co-morbidities, and for those with limited health and social support. CONCLUSION: Regular contact with community nursing services can, at least for some patients, support the development of patient self-efficacy in managing aspects of their own care. Some patients are sufficiently confident to self-manage some treatment side effects by treatment cycle four.

Statistical analysis plan for the coaching for healthy AGEing trial - a cluster-randomised controlled trial to enhance physical activity and prevent falls in community-dwelling older people.

BACKGROUND: This statistical analysis plan details the Coaching for Healthy AGEing (CHAnGE) trial analysis methodology. OBJECTIVE: To investigate the effect of a combined physical activity and fall prevention program on physical activity and falls compared to a healthy eating among people aged 60 years and over. METHODS: The CHAnGE trial is a pragmatic parallel-group cluster-randomised controlled trial with allocation concealment and blinded assessors. Clusters are allocated to either (1) a physical activity and fall prevention intervention or (2) to a healthy eating intervention. The primary outcomes are: objectively measured physical activity at 12 months post-randomisation, and self-reported falls throughout the 12-month trial period. Secondary outcomes include the proportion of participants reporting a fall, the proportion of participants meeting the Australian physical activity guidelines, body mass index, eating habits, mobility goal attainment, mobility-related confidence, quality of life, fear of falling, risk-taking behaviour, mood, well-being, self-reported physical activity, disability, and use of health and community services. ANALYSIS: We will follow the intention-to-treat principle. All analysis will allow for cluster randomisation using a generalised estimating equation approach. The between-group difference in the number of falls per person-year will be analysed using negative binomial regression models. For the continuously scored primary and secondary outcome measures, linear regression models adjusted for corresponding baseline scores will assess the effect of group allocation. Analyses will take into account cluster randomisation and will be adjusted for baseline scores. A subgroup analysis will assess differential effects of the intervention by baseline physical activity levels and history of falls.

Comparison of costs related to infant hospitalisations for spontaneous, induced and Caesarean births: population-based cohort study.

Objective This study examined hospitalisations and associated in-patient costs for babies during the first year of life following spontaneous labour, compared with labour induction or prelabour Caesarean section, at each gestational age. Methods Birth data for singleton liveborn babies from 33 weeks gestation in New South Wales from 2005 to 2014 were linked to hospital and death data. Generalised linear models were used to examine the association between the type of labour and the length of hospitalisations and hospital costs. Results From 2005 to 2014, 598640 women gave birth to 1187451 liveborn singleton babies. The mean total length of hospitalisations and costs of hospitalisations for babies in the first year of life decreased significantly as week of gestational age increased to 39 weeks, then plateaued. Overall, the total length of hospitalisations and hospital costs were significantly (P<0.001) lower for babies born after spontaneous labour (5.6 days and A$8405 respectively) than for babies born following labour induction (6.1 days and A$9452 respectively) or prelabour Caesarean section (8.2 days and A$12320 respectively). Conclusions Babies born following spontaneous labour spend less time in hospital and have lower hospital costs than those born following labour induction or prelabour Caesarean section. Hospitalisations and costs decrease with each week of gestational age until 39 weeks. What is known about the topic? It is known that induction of labour and prelabour Caesarean sections are increasing, and this increase has changed the distribution of gestational age towards birth at earlier ages. It is also known that babies born before 39 weeks of gestation are at increased risk of mortality and morbidity. What does this paper add? This study shows that babies born following spontaneous labour spend the least amount of time in hospital and subsequently have the lowest hospital costs at each week of gestation compared with babies born following labour induction or prelabour Caesarean section. This study also shows a small but significant economic advantage of labour induction compared with prelabour Caesarean delivery. This study quantifies the mean time babies spend in hospital in their first year of life, by week of gestational age and mode of birth. What are the implications for practitioners? The findings from this study can assist clinicians in judicious decision making when balancing the risks and benefits of early planned births. Clinicians can use the results of this study to inform women who are intending to have a planned birth of risks they may not have anticipated, such as the increased risk of rehospitalisation. The finding that hospitalisations and costs continue to decline until 39 weeks gestation can be used to reinforce the importance of continuing the pregnancy beyond 37 weeks if safe to do so, even though 37 weeks is considered term.

Effect of probiotics on multi-resistant organism colonisation in persons with spinal cord injury: secondary outcome of ProSCIUTTU, a randomised placebo-controlled trial.

STUDY DESIGN: Randomised double-blind placebo-controlled trial. OBJECTIVES: Multi-resistant organism (MRO) colonisation is common in people with SCI. We aimed to determine whether Lactobacillus reuteri RC-14 + Lactobacillus GR-1 (RC14-GR1) and/or Lactobacillus rhamnosus GG + Bifidobacterium BB-12 (LGG-BB12) are effective in preventing or clearing MRO colonisation. SETTING: New South Wales, Australia. METHODS: The 207 SCI participants were randomised to one of four arms: (i) RC14-GR1 + LGG-BB12, (ii) RC14-GR1 + placebo, (iii) LGG-BB12 + placebo or (iv) double placebos for 6 months. Microbiological samples of nose, groin, urine and bowel were taken at baseline, 3 and 6 months. Analysis was conducted for the presence of methicillin-resistant Staphylococcus aureus (MRSA), multi-resistant gram-negative organisms (MRGNs) and vancomycin-resistant enterococcus (VRE). The outcomes were clearance of, or new colonisation with MRSA, MRGN, VRE or MROs and whether participants remained free of MRSA, MRGN, VRE or MROs throughout the study. Risk factors associated with an outcome were adjusted for using nominal or binary logistic regression. RESULTS: There was a significant reduction in new MRGN colonisation compared with placebo for participants treated with RC14-GR1 (OR 0.10, 95% CI, 0.01-0.88, P = 0.04), after allowing that inpatients were more likely to be newly colonised (OR 21.41, 95% CI, 3.98-115.13, P < 0.0001). Participants who intermittent self-catheterised (IMC) were more likely to remain MRO-free than those utilising SPC or IDCs (OR 2.80, 95% CI, 1.41-5.54, P = 0.009). CONCLUSIONS: Probiotics are ineffective at clearing MROs in people with SCI. However, RC14-GR1 is effective at preventing new colonisation with MRGNs. The use of IMC significantly improves the chance of remaining MRO-free.

Feasibility and potential effects of interdisciplinary home-based reablement program (I-HARP) for people with cognitive and functional decline: a pilot trial.

Objectives: To test feasibility and potential effects of the interdisciplinary Home-bAsed Reablement Program (I-HARP) that integrates evidence-based strategies and cognitive rehabilitation techniques into a dementia-specific, bio-behavioural-environmental intervention.Methods: A parallel-group randomised controlled pilot trial was conducted in Sydney, Australia, targeting community-dwelling people with amnestic mild cognitive impairment or mild/moderate stages of dementia and their carer (n = 18 dyads). I-HARP comprised: up to 12 home visits by registered nurse, occupational therapist, and psychologist, tailored to the individual client's needs;

Strategies for recruitment in general practice settings: the iSOLVE fall prevention pragmatic cluster randomised controlled trial.

BACKGROUND: Falls are common among older people, and General Practitioners (GPs) could play an important role in implementing strategies to manage fall risk. Despite this, fall prevention is not a routine activity in general practice settings. The iSOLVE cluster randomised controlled trial aimed to evaluate implementation of a fall prevention decision tool in general practice. This paper sought to describe the strategies used and reflect on the enablers and barriers relevant to successful recruitment of general practices, GPs and their patients. METHODS: Recruitment was conducted within the geographical area of a Primary Health Network in Northern Sydney, Australia. General practices and GPs were engaged via online surveys, mailed invitations to participate, educational workshops, practitioner networks and promotional practice visits. Patients 65 years or older were recruited via mailed invitations, incorporating the practice letterhead and the name(s) of participating GP(s). Observations of recruitment strategies, results and enabling factors were recorded in field notes as descriptive and narrative data, and analysed using mixed-methods. RESULTS: It took 19 months to complete recruitment of 27 general practices, 75 GPs and 560 patients. The multiple strategies used to engage general practices and GPs were collectively useful in reaching the targeted sample size. Practice visits were valuable in engaging GPs and staff, establishing interest in fall prevention and commitment to the trial. A mix of small, medium and large practices were recruited. While some were recruited as a whole-practice, other practices had few or half of the number of GPs recruited. The importance of preventing falls in older patients, simplicity of research design, provision of resources and logistic facilitation of patient recruitment appealed to GPs. Recruitment of older patients was successfully achieved by mailed invitations which was a strategy that was familiar to practice staff and patients. Patient response rates were above the expected 10% for most practices. Many practices (n = 17) achieved the targeted number of 20 or more patients. CONCLUSIONS: Recruitment in general practice settings can be successfully achieved through multiple recruitment strategies, effective communication and rapport building, ensuring research topic and design suit general practice needs, and using familiar communication strategies to engage patients. TRIAL REGISTRATION: The trial was prospectively registered on 29 April 2015 with the Australian New Zealand Clinical Trial Registry www.anzctr.org.au (trial ID: ACTRN12615000401550).

Haemoglobin trajectories during pregnancy and associated outcomes using pooled maternity and hospitalization data from two tertiary hospitals.

BACKGROUND AND OBJECTIVES: This study aimed to describe how haemoglobin trajectories in pregnant Australian women were associated with subsequent postpartum haemorrhage, blood transfusion and other outcomes. MATERIALS AND METHODS: The study was conducted in two tertiary public hospitals in Australia, using routinely collected maternity and hospital data on singleton pregnancies (2011-2015). Latent class growth modelling defined trajectories among those with at least one haemoglobin in each of three antenatal time periods (0-15, 16-30 and 31+ weeks; n = 7104). Observed over expected ratios were calculated after predicting expected outcomes with adjusted logistic regression. RESULTS: The mean minimum haemoglobin levels across the three periods were 127·9, 116·5 and 119·3 g/l. We identified seven groups of women with similar haemoglobin trajectories: five with parallel U-shaped trajectories, one with increasing and one with decreasing trajectory. Thirty-eight women (0.5%) had very low haemoglobin across the pregnancy and the highest adverse outcomes, including higher than expected blood transfusion risk. One hundred thirteen women (1.6%) with a progressively decreasing trajectory also had higher risk of transfusion. Women with high haemoglobin across the antenatal period had higher than expected risk of preterm birth, small for gestational age and infants transferred to higher care. CONCLUSIONS: Haemoglobin trajectories across pregnancy can predict women at higher risk of requiring transfusion around birth. Women who maintain high haemoglobins across the pregnancy are worthy of increased surveillance as they carry increased risks of newborn morbidity.

A pragmatic randomised controlled trial (RCT) and realist evaluation of the interdisciplinary home-bAsed Reablement program (I-HARP) for improving functional independence of community dwelling older people with dementia: an effectiveness-implementation hybrid design.

BACKGROUND: A major gap exists internationally in providing support to maintain functional and social independence of older people with dementia living at home. This project evaluates a model of care that integrates evidence-based strategies into a person-centred interdisciplinary rehabilitation package: Interdisciplinary Home-bAsed Reablement Program (I-HARP). Two central aims are: 1) to determine the effectiveness of I-HARP on functional independence, mobility, quality of life and depression among people with dementia, their home environmental safety, carer burden and quality of life, and I-HARP cost-effectiveness; and 2) to evaluate the processes, outcomes and influencing factors of the I-HARP implementation. METHODS: I-HARP is a 4-month model of care, integrated in community aged care services and hospital-based community geriatric services, and consists of: 1) 8-12 home visits, tailored to the individual client's needs, by an occupational therapist, registered nurse, and other allied health staff; 2) minor home modifications/assistive devices to the value of 60 years with mild to moderate dementia and his/her carer). During Phase I, I-HARP advisory group is established and training of I-HARP interventionists is completed, and the effectiveness of I-HARP is examined using a pragmatic RCT. Phase II, conducted concurrently with Phase I, focuses on the process evaluation of the I-HARP implementation using a realist approach. Semi-structured interviews with participants and focus groups with I-HARP interventionists and participating site managers will provide insights into the contexts, mechanisms and outcomes of I-HARP. DISCUSSION: I-HARP is being evaluated within the real-world systems of hospital-based and community-based aged care services in Australia. Future directions and strategies for reablement approaches to care for community dwelling people living with dementia, will be developed. The study will provide evidence to inform key stakeholders in their decision making and the use/delivery of the program, as well as influence future systems-thinking and changes for dementia care. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTR N12618000600246 (approved 18/04/2018).

Linking two randomised controlled trials for Healthy Beginnings©: optimising early obesity prevention programs for children under 3 years.

BACKGROUND: Beginning in 2017 we have conducted a 3-arm randomised controlled trial (RCT) to determine the effectiveness of an early obesity intervention in the first two years of life using either telephone or Short Message Service (SMS) support for mothers. The trial recruited 1155 mothers from their third trimester of pregnancy. This protocol is for a new trial to build on the existing trial using the mother-child dyads retained at 24 months for recruitment to the new RCT. The aim of this new trial is to test whether use of a combination of telephone and SMS interventions is effective in promoting healthy eating and physical activity, as well as reducing child body mass index (BMI) at 3 years of age. METHODS: We will conduct a parallel RCT with an estimated sample of 750 mother-child dyads retained from the existing trial at 24 months. Mothers who completed the 24 months survey, including a telephone survey and measurement of child's height and weight will be invited to participate in the new trial. Informed consent will be obtained at the 24 months survey. The participating mother-child dyads will then be randomly allocated to the intervention (combined telephone and text messaging intervention) or the control group. The intervention will comprise three staged telephone consultations and text messages after each of the three intervention booklets is mailed to mothers at specific time-points between two and three years of child age. The main trial outcome measures include a) BMI and BMI z-score measured at 36 months, b) diet, physical activity and screen time c) cost-effectiveness, and d) feasibility and acceptability of the intervention. DISCUSSION: This unique opportunity to link two studies will expedite project start up time, utilise existing research infrastructure and systems to run the study, and optimise the use of an already engaged population of study participants. It can address a significant knowledge gap regarding early obesity prevention for children aged 2 to 3 years. The feasibility and effectiveness of the combined telephone and SMS intervention will indicate whether this is a scaleable, broad-reach and low-cost early obesity intervention. TRIAL REGISTRATION: The trial was registered with the Australian Clinical Trial Registry ( ACTRN12618001571268 ) on 20/09/2018.

A large proportion of poor birth outcomes among Aboriginal Western Australians are attributable to smoking, alcohol and substance misuse, and assault.

BACKGROUND: Aboriginal infants have poorer birth outcomes than non-Aboriginal infants. Harmful use of tobacco, alcohol, and other substances is higher among Aboriginal women, as is violence, due to factors such as intergenerational trauma and poverty. We estimated the proportion of small for gestational age (SGA) births, preterm births, and perinatal deaths that could be attributed to these risks. METHODS: Birth, hospital, mental health, and death records for Aboriginal singleton infants born in Western Australia from 1998 to 2010 and their parents were linked. Using logistic regression with a generalized estimating equation approach, associations with birth outcomes and population attributable fractions were estimated after adjusting for demographic factors and maternal health during pregnancy. RESULTS: Of 28,119 births, 16% of infants were SGA, 13% were preterm, and 2% died perinatally. 51% of infants were exposed in utero to at least one of the risk factors and the fractions attributable to them were 37% (SGA), 16% (preterm) and 20% (perinatal death). CONCLUSIONS: A large proportion of adverse outcomes were attributable to the modifiable risk factors of substance use and assault. Significant improvements in Aboriginal perinatal health are likely to follow reductions in these risk factors. These results highlight the importance of identifying and implementing risk reduction measures which are effective in, and supported by, Aboriginal women, families, and communities.

Probiotics [LGG-BB12 or RC14-GR1] versus placebo as prophylaxis for urinary tract infection in persons with spinal cord injury [ProSCIUTTU]: a randomised controlled trial.

STUDY DESIGN: Randomised double-blind factorial-design placebo-controlled trial. OBJECTIVE: Urinary tract infections (UTIs) are common in people with spinal cord injury (SCI). UTIs are increasingly difficult to treat due to emergence of multi-resistant organisms. Probiotics are efficacious in preventing UTIs in post-menopausal women. We aimed to determine whether probiotic therapy with Lactobacillus reuteri RC-14+Lactobacillus GR-1 (RC14-GR1) and/or Lactobacillus rhamnosus GG+Bifidobacterium BB-12 (LGG-BB12) are effective in preventing UTI in people with SCI. SETTING: Spinal units in New South Wales, Australia with their rural affiliations. METHODS: We recruited 207 eligible participants with SCI and stable neurogenic bladder management. They were randomised to one of four arms: RC14-GR1+LGG-BB12, RC14-GR1+placebo, LGG-BB12+ placebo or double placebos for 6 months. Randomisation was stratified by bladder management type and inpatient or outpatient status. The primary outcome was time to occurrence of symptomatic UTI. RESULTS: Analysis was based on intention to treat. Participants randomised to RC14-GR1 had a similar risk of UTI as those not on RC14-GR1 (HR 0.67; 95% CI: 0.39-1.18; P = 0.17) after allowing for pre-specified covariates. Participants randomised to LGG-BB12 also had a similar risk of UTI as those not on LGG-BB12 (HR 1.29; 95% CI: 0.74-2.25; P = 0.37). Multivariable post hoc survival analysis for RC14-GR1 only vs. the other three groups showed a potential protective effect (HR 0.46; 95% CI: 0.21-0.99; P = 0.03), but this result would need to be confirmed before clinical application. CONCLUSION: In this RCT, there was no effect of RC14-GR1 or LGG-BB12 in preventing UTI in people with SCI.

Maternal fetal programming of birthweight among Australian Aboriginal infants: a population-based data linkage study.

BACKGROUND: Low birthweight, which is common among Australian Aboriginal infants, has been found to persist across generations because of shared genetic and environmental factors and possibly fetal programming. Fetal programming refers to the response of a fetus to hostile uterine conditions with lifelong effects and possibly, in turn, providing a poorer uterine environment for future offspring. Fetal programming might have a greater effect in populations that have undergone rapid lifestyle transitions-for example, Indigenous populations. Disentangling causal effects is difficult, but family-based approaches could provide insights. We explored whether poor maternal fetal growth caused low birthweight in Aboriginal infants. METHODS: In this data linkage study, we used linked administrative health records of 12 865 singleton Aboriginal infants born in Western Australia between 1980 and 2010 and their relatives (including siblings born in 2011). Electronic birth records included all births since 1980 with at least 20 weeks completed gestation or a birthweight of 400 g. We compared parental-offspring birthweight associations using three approaches-a regression analysis of the complete sample, adjusting for confounding variables; a comparison of the maternal-offspring and paternal-offspring associations; and a within-cousin group comparison. We used binary and continuous measures of birthweight. We categorised infants and their parents as small for gestational age (SGA) if their birthweight was below the first decile of birthweights for all singleton livebirths of the same sex and gestational age in Australia between 1998 and 2007. FINDINGS: The relative risk (RR) of SGA birth was higher for infants with SGA mothers than for those with non-SGA mothers (RR 1·65, 95% CI 1·49 to 1·83), after adjusting for grandmaternal parity. After additional adjustment for maternal height, the risk remained higher for those with non-SGA mothers (RR 1·51, 1·36 to 1·68). The maternal birthweight Z score coefficient was 0·17 (95% CI 0·14 to 0·20), compared with 0·13 (0·10 to 0·16) for paternal birthweight, a difference of 0·03 (-0·01 to 0·08). In the cousin analysis, the maternal-offspring association was fully attenuated (0·00, 95% CI -0·05 to 0·06). Conditions in the current pregnancy were strongly associated with offspring birthweight Z score. Smoking was associated with a mean decrease of 0·39 (95% CI -0·45 to -0·34) in offspring birthweight Z score, drug misuse with a decrease of 0·31 (-0·43 to -0·20), and diabetes with an increase of 0·58 (0·39 to 0·77). INTERPRETATION: We found little support for maternal fetal programming causing low offspring birthweight. The similar maternal and paternal influence on birthweight and our cousin analysis suggested transmission of genetic and environmental factors could explain much of the maternal-offspring birthweight association. Compared with other risk factors in the current pregnancy, fetal programming appears to have little or no role in the high numbers of infants with low birthweight among Aboriginal populations. FUNDING: National Health and Medical Research Council of Australia and Bellberry Ltd.

Assessing the effect of risk factors on rates of obstetric transfusion over time using two methodological approaches.

BACKGROUND: While red blood cell transfusion rates have declined in most Australian medical specialties, obstetric transfusion rates have instead been increasing. Obstetric transfusions are mostly linked to postpartum haemorrhage, the rates of which have also increased over time. This study used two methodological approaches to investigate recent trends in obstetric transfusion in New South Wales (NSW) and the extent to which this was influenced by changing maternal and pregnancy characteristics. METHODS: Linked birth and hospital records were used to examine rates of red blood cell transfusion in the postpartum period for mothers giving birth in NSW hospitals from 2005 to 2015. Logistic regression models were run to examine the contribution of maternal and pregnancy risk factors to changing rates of transfusion. Risk factors were divided into "pre-pregnancy" and "pregnancy related". Crude and adjusted estimates of the effect of year of birth on obstetric transfusion rates were compared to assess the effect of risk factors on rates over time using two approaches. The first compared actual and predicted odds ratios of transfusion for each year. The second compared the observed increase in transfusion rate with that predicted after controlling for the risk factors. RESULTS: Among 935,659 births, the rate of obstetric transfusion rose from 13 per 1000 births in 2005 to 17 in 2011, and remained stable until 2015. From 2005 to 2015, postpartum haemorrhage increased from 74 to 114 per 1000 births. Compared with the rate in 2005, the available maternal and pregnancy characteristics only partially explained the change in rate of transfusion by 2015 (Method 1, crude odds ratio 1.39 (95% CI 1.25, 1.56); adjusted odds ratio 1.29 (95% CI 1.15, 1.45)). After adjustment for maternal and pregnancy characteristics, obstetric transfusion incidence was predicted to increase by 10.3%, but a 38.7% increase was observed (Method 2). CONCLUSION: Rates of obstetric transfusion have stabilised after a period of increase. The trend could not be fully explained by measured maternal and pregnancy characteristics with either of the two approaches. Further investigation of rates and maternal and clinical risk factors will help to inform and improve obstetric blood product use.

Antecedents of Abnormally Invasive Placenta in Primiparous Women: Risk Associated With Gynecologic Procedures.

OBJECTIVE: To evaluate the association between prior invasive gynecologic procedures and the risk of subsequent abnormally invasive placenta (ie, placenta accreta, increta, and percreta). METHODS: We conducted a population-based data linkage study including all primiparous women who delivered in New South Wales, Australia, between 2003 and 2012. Data were obtained from linked birth and hospital admissions with a minimum lookback period of 2 years. Prior procedures invasive of the uterus were considered including gynecologic laparoscopy with instrumentation of the uterus; hysteroscopy, including operative hysteroscopy; curettage, including suction curettage and surgical termination; and endometrial ablation. Modified Poisson regression was used to determine the association between the number of prior gynecologic procedures and risk of abnormally invasive placenta. RESULTS: Eight hundred fifty-four cases of abnormally invasive placenta were identified among 380,775 deliveries included in the study (22.4/10,000). In total, 33,296 primiparous women had at least one prior procedure (8.7%). Among women with abnormally invasive placenta, 152 (17.8%) had undergone at least one procedure compared with 33,144 (8.7%) among women without abnormally invasive placenta (P<.01). After adjustment, the relative risk was 1.5 for one procedure (99% CI 1.1-1.9), 2.7 for two procedures (99% CI 1.7-4.4), and 5.1 for three or more procedures (99% CI 2.7-9.6). Abnormally invasive placenta was also positively associated with maternal age, socioeconomic advantage, mother being Australia-born, placenta previa, hypertension, multiple births, use of assisted reproductive technology, and female fetal sex. CONCLUSION: Women with a history of prior invasive gynecologic procedures were more likely to develop abnormally invasive placenta. These insights may be used to inform management of pregnancies in women with a history of gynecologic procedures.

Comorbidities Only Account for a Small Proportion of Excess Mortality After Fracture: A Record Linkage Study of Individual Fracture Types.

Nonhip, nonvertebral (NHNV) fractures constitute the majority of osteoporotic fractures, but few studies have examined the association between these fractures, comorbidity, and mortality. Our objective was to examine the relationship between individual nonhip, nonvertebral fractures, comorbidities, and mortality. The prospective population-based cohort of 267,043 subjects (45 and Up Study, Australia) had baseline questionnaires linked to hospital administrative and all-cause mortality data from 2006 to 2013. Associations between fracture and mortality were examined using multivariate, time-dependent Cox models, adjusted for age, prior fracture, body mass index, smoking, and comorbidities (cardiovascular disease, diabetes, stroke, thrombosis, and cancer), and survival function curves. Population attributable fraction was calculated for each level of risk exposure. During 1,490,651 person-years, women and men experienced 7571 and 4571 fractures and 7064 deaths and 11,078 deaths, respectively. In addition to hip and vertebral fractures, pelvis, humerus, clavicle, rib, proximal tibia/fibula, elbow and distal forearm fractures in both sexes, and ankle fractures in men were associated with increased multivariable-adjusted mortality hazard ratios ranging from 1.3 to 3.4. Comorbidity independently added to mortality such that a woman with a humeral fracture and 1 comorbidity had a similarly reduced 5-year survival as that of a woman with a hip fracture and no comorbidities. Population mortality attributable to any fracture without comorbidity was 9.2% in women and 5.3% in men. All proximal nonhip, nonvertebral fractures in women and men were associated with increased mortality risk. Coexistent comorbidities independently further increased mortality. Population attributable risk for mortality for fractures was similar to cardiovascular disease and diabetes, highlighting their importance and potential benefit for early intervention and treatment. © 2018 American Society for Bone and Mineral Research.