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.

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.

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.

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;

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.

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).

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.

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.

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.

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.

Differences Between Landline and Mobile Phone Users in Sexual Behavior Research.

This study investigated differences between the demographic characteristics, participation rates (i.e., agreeing to respond to questions about sexual behavior), and sexual behaviors of landline and mobile phone samples in Australia. A nationally representative sample of Australians aged 18 years and over was recruited via random digit dialing in December 2011 to collect data via computer-assisted telephone interviews. A total of 1012 people (370 men, 642 women) completed a landline interview and 1002 (524 men, 478 women) completed a mobile phone interview. Results revealed that telephone user status was significantly related to all demographic variables: gender, age, educational attainment, area of residence, country of birth, household composition, and current ongoing relationship status. In unadjusted analyses, telephone status was also associated with women's participation rates, participants' number of other-sex sexual partners in the previous year, and women's lifetime sexual experience. However, after controlling for significant demographic factors, telephone status was only independently related to women's participation rates. Post hoc analyses showed that significant, between-group differences for all other sexual behavior outcomes could be explained by demographic covariates. Results also suggested that telephone status may be associated with participation bias in research on sexual behavior. Taken together, these findings highlight the importance of sampling both landline and mobile phone users to improve the representativeness of sexual behavior data collected via telephone interviews.

Probiotics for preventing urinary tract infection in people with neuropathic bladder.

BACKGROUND: Neuropathic or neurogenic bladder describes a process of dysfunctional voiding as the result of injury in the brain, spinal cord or nerves innervating the bladder. People with neuropathic bladder, such as from spinal cord injury (SCI), are at significant risk of morbidity from urinary tract infections (UTI). Effective methods to prevent UTI in people with SCI have been sought for many years. Probiotics (micro-organisms that exert beneficial health effects in the host) have been recommended for bacterial interference of the urological tract to reduce colonisation by uropathogen and to manage the dual problems of infection and antibiotic resistance. OBJECTIVES: This review looked at the benefits and harms of probiotics in preventing symptomatic UTI in people with neuropathic bladder compared with placebo, no therapy, or non-antibiotic prophylaxis (cranberry juice, methenamine hippurate, topical oestrogen). SEARCH METHODS: We searched the Cochrane Kidney and Transplant Specialised Register up to 10 March 2017 through contact with the Information Specialist using search terms relevant to this review. Studies in the Specialised Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov. SELECTION CRITERIA: All randomised controlled trials (RCTs), quasi-RCTs and cross-over RCTs looking at the use of probiotics for the prophylaxis of UTI in people with neuropathic bladders was considered for inclusion. Men, women and children of all ages with neuropathic bladders from neurological injury such as suprapontine, supra sacral and sacral aetiologies was included. All bladder management types, including reflex voiding, time voiding, indwelling and intermittent catheterization were eligible for this review.Studies comparing probiotics to placebo, no treatment or other non-antibiotic prophylaxis was included. Studies comparing probiotics with antibiotics or in combination with antibiotics were excluded. DATA COLLECTION AND ANALYSIS: Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) or standardised mean difference (SMD) and 95% CI were planned for continuous outcomes. MAIN RESULTS: This review includes a total of three studies (one cross-over and two parallel RCTs) which involved 110 participants. All three studies looked at intravesical instillation of a low virulent Escherichia coli (E. coli) strain in reducing the risk of symptomatic UTI in participants with neuropathic bladder, predominantly from SCI. Two studies used the E. coli 83972 strain and one study used the E. coli HU2117 strain.We did not find any RCTs involving other probiotics or other routes of administration for preventing UTI in people with neuropathic bladder.There was consistency in definition of symptomatic UTI in all three studies. Symptoms that all studies considered were relevant to diagnose UTI were adequately defined. All three studies defined microbiological diagnosis of symptomatic UTI.Asymptomatic bacteriuria was not considered an outcome measure in any of the included studies; however it was defined in two studies to establish successful inoculation.It is uncertain if the risk of symptomatic UTI is reduced with bladder inoculation using E. coli because the certainty of the evidence is very low (3 studies, 110 participants: RR 0.32, 95% CI 0.08 to 1.19; I2 = 82%).Two studies reported adverse events. One study reported one episode of autonomic dysreflexia. One study reported three symptomatic UTI occurring in two patients, and two studies mentioned the absence of septicaemia and pyelonephritis. Intravesical instillation was reported as "generally safe". One study reported high attrition rates in participants due to the need to adhere to strict instillation protocols.The overall quality of the studies was poor. All three studies had high risk of attrition bias due to failure of an intention-to-treat analysis which undermines the randomisation process and weakened the results of the studies. All three studies also had high risk of reporting bias. AUTHORS' CONCLUSIONS: In this review, there were no studies identified addressing oral probiotics in preventing UTI in people with neuropathic bladder. It is uncertain if the risk of symptomatic UTI is reduced in people with neuropathic bladders via intravesical instillation of non-pathogenic E. coli as data were derived from small studies with high risk of bias.Although very minimal levels of harm was reported with this procedure, due to variable success rates, the need for strict adherence to instillation protocols together with high attrition rates in these studies, it is doubtful bladder instillation will be a widely accepted intervention in its current form.It is recommended that further appropriately powered RCTs with more robust methodological reporting be carried out.

Maternal and neonatal outcomes following abnormally invasive placenta: a population-based record linkage study.

INTRODUCTION: Abnormally invasive placenta involves abnormal adherence of the placenta to the myometrium and is associated with severe pregnancy complications such as blood transfusion and hysterectomy. Knowledge of outcomes has been limited by small sample sizes and a focus on maternal rather than neonatal outcomes. This study uses population-level data collected over 10 years to investigate maternal and neonatal outcomes and trends in incidence of abnormally invasive placenta (also known as placenta accreta, increta and percreta). MATERIAL AND METHODS: A population-based record linkage study was performed, including all women who gave birth in New South Wales, Australia, between 2003 and 2012. Data were obtained from birth records, hospital admissions and deaths registrations. Modified Poisson regression models, adjusted for confounding factors, were used to quantify the effect of abnormally invasive placenta on adverse maternal and neonatal outcomes. RESULTS: Abnormally invasive placenta was significantly associated with morbidity for mothers (adjusted relative risk 17.6, 99% confidence interval 14.5-21.2) and infants (adjusted relative risk 3.1, 99% confidence interval 2.7-3.5). Abnormally invasive placenta increased risk of stillbirth (relative risk 5.4, 99% confidence interval 4.0-7.3) and neonatal death (relative risk 8.0, 99% confidence interval 1.5-41.6). The overall rate of abnormally invasive placenta was 24.8 per 10 000 deliveries, and 22.7 per 10 000 among primiparae. Incidence increased by 30%, from 20.6 to 26.9 per 10 000, over the 10-year study period. CONCLUSIONS: Abnormally invasive placenta substantially increases the risk of severe adverse outcomes for mothers and babies, and the incidence is increasing. Delivery should occur in tertiary hospitals equipped with neonatal intensive care units. Clinicians should be cognizant of the risks, particularly to infants, and maintain a high index of suspicion of abnormally invasive placenta, including in primiparae.

Social Dancing and Incidence of Falls in Older Adults: A Cluster Randomised Controlled Trial.

BACKGROUND: The prevention of falls among older people is a major public health challenge. Exercises that challenge balance are recognized as an efficacious fall prevention strategy. Given that small-scale trials have indicated that diverse dance styles can improve balance and gait of older adults, two of the strongest risk factors for falls in older people, this study aimed to determine whether social dance is effective in i) reducing the number of falls and ii) improving physical and cognitive fall-related risk factors. METHODS AND FINDINGS: A parallel two-arm cluster randomized controlled trial was undertaken in 23 self-care retirement villages (clusters) around Sydney, Australia. Eligible villages had to have an appropriate hall for dancing, house at least 60 residents, and not be currently offering dance as a village activity. Retirement villages were randomised using a computer generated randomisation method, constrained using minimisation. Eligible participants had to be a resident of the village, be able to walk at least 50 m, and agree to undergo physical and cognitive testing without cognitive impairment. Residents of intervention villages (12 clusters) were offered twice weekly one-hour social dancing classes (folk or ballroom dancing) over 12 mo (80 h in total). Programs were standardized across villages and were delivered by eight dance teachers. Participants in the control villages (11 clusters) were advised to continue with their regular activities. MAIN OUTCOMES: falls during the 12 mo trial and Trail Making Tests. SECONDARY OUTCOMES: The Physiological Performance Assessment (i.e., postural sway, proprioception, reaction time, leg strength) and the Short Physical Performance Battery; health-related physical and mental quality of life from the Short-Form 12 (SF-12) Survey. Data on falls were obtained from 522 of 530 (98%) randomised participants (mean age 78 y, 85% women) and 424 (80%) attended the 12-mo reassessment, which was lower among folk dance participants (71%) than ballroom dancing (82%) or control participants (82%, p = 0.04). Mean attendance at dance classes was 51%. During the period, 444 falls were recorded; there was no significant difference in fall rates between the control group (0.80 per person-year) and the dance group (1.03 per person-year). Using negative binomial regression with robust standard errors the adjusted Incidence Rate Ratio (IRR) was 1.19 (95% CI: 95% CI = 0.83, 1.71). In exploratory post hoc subgroup analysis, the rate of falls was higher among dance participants with a history of multiple falls (IRR = 2.02, 95% CI: 1.15, 3.54, p = 0.23 for interaction) and with the folk dance intervention (IRR = 1.68, 95% CI: 1.03, 2.73). There were no significant between-group differences in executive function test (TMT-B = 2.8 s, 95% CI: -6.2, 11.8). Intention to treat (ITT) analysis revealed no between-group differences at 12-mo follow-up in the secondary outcome measures, with the exception of postural sway, favouring the control group. Exploratory post hoc analysis by study completers and style indicated that ballroom dancing participants apparently improved their gait speed by 0.07 m/s relative to control participants (95% CI: 0.00, 0.14, p = 0.05). Study limitations included allocation to style based on logistical considerations rather than at random; insufficient power to detect differential impacts of different dance styles and smaller overall effects; variation of measurement conditions across villages; and no assessment of more complex balance tasks, which may be more sensitive to changes brought about by dancing. CONCLUSIONS: Social dancing did not prevent falls or their associated risk factors among these retirement villages' residents. Modified dance programmes that contain "training elements" to better approximate structured exercise programs, targeted at low and high-risk participants, warrant investigation. TRIAL REGISTRATION: The Australian New Zealand Clinical Trials Registry ACTRN12612000889853.

Change in the manifestations of asthma and asthma-related traits in childhood: a latent transition analysis.

It is known that asthma is a heterogeneous entity whose manifestations vary with age. Our objective was to examine changes in the manifestation of asthma and asthma-related traits in childhood by defining empirically derived childhood asthma phenotypes and examining their transitions over time.To define the phenotypes we used data on respiratory symptoms, healthcare utilisation, medications, spirometry, airway hyperresponsiveness (AHR), exhaled nitric oxide concentration and atopy from a birth cohort recruited on the basis of having a first-degree relative with asthma. Data were acquired at ages 1.5-11.5 years and analysed using latent transition analysis.In a study population of 370 participants, we classified subjects into four phenotypes: 1) nonatopic, few symptoms (prevalence range from 1.5 to 5 years: 52-60%), 2) atopic, few symptoms (3-21%), 3) nonatopic, asthma and rhinitis symptoms (13-35%), and 4) atopic, asthma and rhinitis symptoms (2-14%) in early childhood; and 1) nonatopic, no respiratory disease (prevalence range from 8 to 11.5 years: 41-46%), 2) atopic, no respiratory disease (23-33%), 3) nonatopic, asthma symptoms, no AHR or airway inflammation (8-12%) and 4) atopic asthma (19%) in mid-childhood. Transitioning between phenotypes was common in early childhood, but less common in later childhood.This analysis represents the first attempt to incorporate longitudinal patterns of several manifestations of asthma into a single model to simultaneously define phenotypes and examine their transitions over time. It provides quantitative support for the view that asthma is a heterogeneous entity, and that some children with wheeze and other respiratory symptoms in early life progress to asthma in mid-childhood, while others become asymptomatic.

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

BACKGROUND: Urinary tract infections [UTIs] are very common in people with Spinal Cord Injury [SCI]. UTIs are increasingly difficult and expensive to treat as the organisms that cause them become more antibiotic resistant. Among the SCI population, there is a high rate of multi-resistant organism [MRO] colonisation. Non-antibiotic prevention strategies are needed to prevent UTI without increasing resistance. Probiotics have been reported to be beneficial in preventing UTIs in post-menopausal women in several in vivo and in vitro studies. The main aim of this study is to determine whether probiotic therapy with combinations of Lactobacillus reuteri RC-14 + Lactobacillus rhamnosus GR-1 [RC14-GR1] and/or Lactobacillus rhamnosus GG + Bifidobacterium BB-12 [LGG-BB12] are effective in preventing UTI in people with SCI compared to placebo. METHOD: This is a multi-site randomised double-blind double-dummy placebo-controlled factorial design study conducted in New South Wales, Australia. All participants have a neurogenic bladder as a result of spinal injury. Recruitment started in April 2011. Participants are randomised to one of four arms, designed for factorial analysis of LGG-BB12 and/or RC14-GR1 v Placebo. This involves 24 weeks of daily oral treatment with RC14-GR1 + LGG-BB12, RC14-GR1 + placebo, LGG-BB12 + placebo or two placebo capsules. Randomisation is stratified by bladder management type and inpatient status. Participants are assessed at baseline, three months and six months for Short Form Health Survey [SF-36], microbiological swabs of rectum, nose and groin; urine culture and urinary catheters for subjects with indwelling catheters. A bowel questionnaire is administered at baseline and three months to assess effect of probiotics on bowel function. The primary outcome is time from randomisation to occurrence of symptomatic UTI. The secondary outcomes are change of MRO status and bowel function, quality of life and cost-effectiveness of probiotics in persons with SCI. The primary outcome will be analysed using survival analysis of factorial groups, with Cox regression modelling to test the effect of each treatment while allowing for the other, assuming no interaction effect. Hazard ratios and Kaplan-Meier survival curves will be used to summarise results. DISCUSSION: If these probiotics are shown to be effective in preventing UTI and MRO colonisation, they would be a very attractive alternative for UTI prophylaxis and for combating the increasing rate of antibiotic resistance after SCI. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry [ ACTRN 12610000512022 ]. Date of registration: 21 June 2010.

Gestational age, mode of birth and breastmilk feeding all influence acute early childhood gastroenteritis: a record-linkage cohort study.

BACKGROUND: Acute gastroenteritis (AGE) is a leading cause of infectious morbidity in childhood. Clinical studies have implicated caesarean section, early birth and formula feeding in modifying normal gut microbiota development and immune system homeostasis in early life. Rates of early birth and cesarean delivery are also increasing worldwide. This study aimed to investigate the independent and combined associations of the mode and timing of birth and breastmilk feeding with AGE hospitalisations in early childhood. METHODS: Population-based record-linkage study of 893,360 singleton livebirths of at least 33 weeks gestation without major congenital conditions born in hospital, New South Wales, Australia, 2001-2011. Using age at first AGE hospital admission, Cox-regression was used to estimate the associations for gestational age, vaginal birth or caesarean delivery by labour onset and formula-only feeding while adjusting for confounders. RESULTS: There were 41,274 (4.6 %) children admitted to hospital at least once for AGE and the median age at first admission was 1.4 years. Risk of AGE admission increased with decreasing gestational age (37-38 weeks: 15 % increased risk, 33-36 weeks: 25 %), caesarean section (20 %), planned birth (17 %) and formula-only feeding (18 %). The rate of AGE admission was highest for children who were born preterm by modes of birth other than vaginal birth following the spontaneous onset of labour and who received formula-only at discharge from birth care (62-78 %). CONCLUSIONS: Vaginal birth following spontaneous onset of labour at 39+ weeks gestation with any breastfeeding minimised the risk of gastroenteritis hospitalisation in early childhood. Given increasing trends in early planned birth and caesarean section worldwide, these results provide important information about the impact obstetric interventions may have on the development of the infant gut microbiota and immunity.