Children's untreated decay is positively associated with past caries experience and with current salivary loads of mutans Streptococci; negatively with self-reported maternal iron supplements during pregnancy: a multifactorial analysis.

OBJECTIVES: This study explored the association of children's salivary characteristics, past caries experience, birth weight, and reported maternal prenatal vitamin and mineral supplementation with the dental untreated decay of the child. METHODS: This cross-sectional study, a sub-study of Griffith University Environments for Healthy Living birth cohort study, was conducted on 174 mother-child dyads. Mother's prenatal usage of vitamin and mineral supplements; child's birthweight; salivary pH, buffering capacity, and levels of salivary MS and LB were explored as risk indicators. Dental caries experience was assessed using International Caries Detection and Assessment System criteria. Path analysis was conducted to evaluate the association of risk indicators with children's current and past dental caries experience. RESULTS: Children's past caries experience (ß = 0.332, p = 0.018), and salivary MS counts (ß = 0.215, p = 0.032) were positively associated with untreated decay at time of examination. With a trend towards significance, children whose mothers had reported taking iron supplements during pregnancy experienced lower levels of past caries (ß = -0.137, p = 0.068) and untreated dental caries (ß = -0.046, p = 0.051). CONCLUSIONS: This study confirms that a child's levels of untreated decay is positively associated with their past caries, and that it correlates with current levels of salivary MS. Children of mothers who reported to have taken iron supplements during pregnancy experienced less caries throughout their lives. These observations confirm the importance to offspring of monitoring maternal health throughout pregnancy and of early monitoring of children's oral health in preventing future dental disease.

Evaluation of the Gold Coast Integrated Care for patients with chronic disease or high risk of hospitalisation through a non-randomised controlled clinical trial: a pilot study protocol.

INTRODUCTION: Chronic diseases are the leading cause of illness, disability and death in Australia. The prevalence and associated health expenditure are projected to soar. There is no 'whole system' approach to healthcare in Australia. To overcome this fragmentation, the Gold Coast Hospital and Health Service (GCHHS) is developing a new model known as Gold Coast Integrated Care (GCIC). To evaluate GCIC a 4-year pilot trial commenced in March 2015. This protocol paper describes the evaluation of GCIC. METHODS AND ANALYSIS: A pragmatic non-randomised controlled clinical trial is conducted to test the hypothesis that GCIC will result in improved health and well-being at no additional cost to the healthcare system. Using a mixed methods approach, impact, outcome and process evaluations will be undertaken to assess the effectiveness and acceptability, including the balance of costs between primary and public secondary care sectors, staff and training requirements, clinical service delivery, and trial implementation.Fifteen general practices have agreed to deliver GCIC. One thousand five hundred of their adult patients with treated chronic diseases, high risk of hospitalisation or healthcare utilisation were recruited to the intervention arm. Approximately 3000 patients not associated with the participating general practices were identified as controls using propensity matching which will provide service utilisation and disease data for usual care.Baseline data and follow-up observations are collected annually until the end of 2018. Quantitative analyses will measure patient healthcare costs, utilisation of health services, and health outcomes, and general practice clinical service delivery according to clinical guidelines (number of foot exams, HbA1c tests). Qualitative analyses will focus on patient and staff experiences, satisfaction, engagement and implementation of the programme as planned. ETHICS AND DISSEMINATION: Approval was received from the GCHHS and Griffith University. The study is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12616000821493). Findings will be communicated via yearly reports to funding bodies and scientific publications. TRIAL REGISTRATION NUMBER: ACTRN12616000821493; Pre-results.

An economic evaluation alongside a randomised controlled trial on psycho-education counselling intervention offered by midwives to address women's fear of childbirth in Australia.

OBJECTIVE: The rate of caesarean section continues to increase, and there is evidence that childbirth fear is a contributing factor. Insufficient evidence is available on the impact of reducing childbirth fear on health-related quality of life and health service use. We undertook an economic evaluation of a psycho-education counselling intervention offered by midwives to address women's fear of childbirth in Australia. METHODS: Pregnant women (n = 339) with high childbirth fear were randomised to a midwife-led psycho-education intervention for childbirth fear or to usual care. This paper presents the economic evaluation of the intervention based on health-related quality of life and health service use from recruitment to six weeks postpartum (n = 184). RESULTS: The changes in health-related quality of life after birth (EQ-5D-3L: 0.016 vs. 0.010, p = 0.833, for usual care and intervention) and total health care use cost (AUS$10,110 vs. AUS$9980, p = 0.819) were similar between groups. The intervention did not increase costs; however, in a post hoc analysis, the interventions might be cost-effective for those women with very high childbirth fear. CONCLUSION: This brief psycho-education intervention by midwives did not improve the health-related quality of life of women, and had no impact on overall cost.

Economic evaluation strategies in telehealth: Obtaining a more holistic valuation of telehealth interventions.

Telehealth is an emerging area of medical research. Its translation from conception, to research and into practice requires tailored research and economic evaluation methods. Due to their nature telehealth interventions exhibit a number of extra-clinical benefits that are relevant when valuing their costs and outcomes. By incorporating methods to measure societal values such as patient preference and willingness-to-pay, a more holistic value can be placed on the extra-clinical outcomes associated with telehealth and evaluations can represent new interventions more effectively. Cost-benefit analysis is a method by which relevant costs and outcomes in telehealth can be succinctly valued and compared. When health economic methods are conducted using holistic approaches such as cost-benefit analysis they can facilitate the translation of telehealth research into policy and practice.

First trimester multivitamin/mineral use is associated with reduced risk of pre-eclampsia among overweight and obese women.

The use of pregnancy-specific multivitamin supplements is widely recommended to support maternal homeostasis during pregnancy. Our objective was to investigate whether multivitamin use during pregnancy is associated with a reduced risk of pre-eclampsia. The effect of multivitamin use on incidence of pre-eclampsia in lean and overweight/obese women was analysed using data collected between 2006 and 2011 as part of the Environments for Healthy Living Project, Griffith University, Australia. A total of 2261 pregnancies were included in the analysis with pre-eclampsia reported in 1.95% of subjects. Body mass index (BMI) ≥ 25 was associated with a 1.97-fold [95% confidence interval (CI): 0.93, 4.16] increase in pre-eclampsia risk. First trimester multivitamin use was reported by 31.8% of women and after adjustment, was associated with a 67% reduction in pre-eclampsia risk (95%CI: 0.14, 0.75). Stratification by BMI demonstrated a 55% reduction in pre-eclampsia risk (95%CI: 0.30, 0.86) in overweight (BMI: 25-29.9) and 62% risk reduction (95%CI: 0.16, 0.92) in obese (BMI: ≥30) cohorts that supplemented with multivitamins in the first trimester of pregnancy. This finding may be particular to the Australian population and reflect inherent nutritional deficits. First trimester folate supplementation was found to reduce pre-eclampsia incidence [adjusted odds ratios (AOR) 0.42 95%CI: 0.13, 0.98] and demonstrated significance upon stratification by overweight status for women with BMI >25 (AOR 0.55 95%CI: 0.31, 0.96). These results support the hypothesis that multivitamin supplementation may be beneficial in reducing the incidence of pre-eclampsia during pregnancy and be of particular importance for those with a BMI ≥25.

Effects of a midwife psycho-education intervention to reduce childbirth fear on women's birth outcomes and postpartum psychological wellbeing.

BACKGROUND: High levels of childbirth fear impact birth preparation, obstetric outcomes and emotional wellbeing for around one in five women living in developed countries. Higher rates of obstetric intervention and caesarean section (CS) are experienced in fearful women. The efficacy of interventions to reduce childbirth fear is unclear, with no previous randomised controlled trials reporting birth outcomes or postnatal psychological wellbeing following a midwife led intervention. METHOD: Between May 2012 and June 2013 women in their second trimester of pregnancy were recruited. Women with a fear score ≥ 66 on the Wijma Delivery Expectancy / Experience Questionnaire (W-DEQ) were randomised to receive telephone psycho-education by a midwife, or usual maternity care. A two armed non-blinded parallel (1:1) multi-site randomised controlled trial with participants allocated in blocks of ten and stratified by hospital site and parity using an electronic centralised computer service. The outcomes of the RCT on obstetric outcomes, maternal psychological well-being, parenting confidence, birth satisfaction, and future birth preference were analysed by intention to treat and reported here. RESULTS: 1410 women were screened for high childbirth fear (W-DEQ ≥66). Three hundred and thirty-nine (n = 339) women were randomised (intervention n = 170; controls n = 169). One hundred and eighty-four women (54 %) returned data for final analysis at 6 weeks postpartum (intervention n = 91; controls n = 93). Compared to controls the intervention group had a clinically meaningful but not statistically significant reduction in overall caesarean section (34 % vs 42 %, p = 0.27) and emergency CS rates (18 % vs 25 %, p = 0.23). Fewer women in the intervention group preferred caesarean section for a future pregnancy (18 % vs 30 %, p = 0.04). All other obstetric variables remained similar. There were no differences in postnatal depression symptoms scores, parenting confidence, or satisfaction with maternity care between groups, but a lower incidence of flashbacks about their birth in the intervention group compared to controls (14 % vs 26 %, p = 0.05). Postnatally women who received psycho-education reported that the 'decision aid' helped reduce their fear (53 % vs 37 %, p = 0.02). CONCLUSION: Following a brief antenatal midwife-led psycho-education intervention for childbirth fear women were less likely to experience distressing flashbacks of birth and preferred a normal birth in a future pregnancy. A reduction in overall CS rates was also found. Psycho-education for fearful women has clinical benefits for the current birth and expectations of future pregnancies. TRIAL REGISTRATION: Australian New Zealand Controlled Trials Registry ACTRN12612000526875 , 17th May 2012.

Effectiveness, cost-effectiveness and cost-benefit of a single annual professional intervention for the prevention of childhood dental caries in a remote rural Indigenous community.

BACKGROUND: The aim of the study is to reduce the high prevalence of tooth decay in children in a remote, rural Indigenous community in Australia, by application of a single annual dental preventive intervention. The study seeks to (1) assess the effectiveness of an annual oral health preventive intervention in slowing the incidence of dental caries in children in this community, (2) identify the mediating role of known risk factors for dental caries and (3) assess the cost-effectiveness and cost-benefit of the intervention. METHODS/DESIGN: The intervention is novel in that most dental preventive interventions require regular re-application, which is not possible in resource constrained communities. While tooth decay is preventable, self-care and healthy habits are lacking in these communities, placing more emphasis on health services to deliver an effective dental preventive intervention. Importantly, the study will assess cost-benefit and cost-effectiveness for broader implementation across similar communities in Australia and internationally. DISCUSSION: There is an urgent need to reduce the burden of dental decay in these communities, by implementing effective, cost-effective, feasible and sustainable dental prevention programs. Expected outcomes of this study include improved oral and general health of children within the community; an understanding of the costs associated with the intervention provided, and its comparison with the costs of allowing new lesions to develop, with associated treatment costs. Findings should be generalisable to similar communities around the world. The research is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), registration number ACTRN12615000693527; date of registration: 3rd July 2015.

The OnTrack Diabetes Web-Based Program for Type 2 Diabetes and Dysphoria Self-Management: A Randomized Controlled Trial Protocol.

BACKGROUND: The prevalence of type 2 diabetes is rising with the majority of patients practicing inadequate disease self-management. Depression, anxiety, and diabetes-specific distress present motivational challenges to adequate self-care. Health systems globally struggle to deliver routine services that are accessible to the entire population, in particular in rural areas. Web-based diabetes self-management interventions can provide frequent, accessible support regardless of time and location OBJECTIVE: This paper describes the protocol of an Australian national randomized controlled trial (RCT) of the OnTrack Diabetes program, an automated, interactive, self-guided Web program aimed to improve glycemic control, diabetes self-care, and dysphoria symptoms in type 2 diabetes patients. METHODS: A small pilot trial is conducted that primarily tests program functionality, efficacy, and user acceptability and satisfaction. This is followed by the main RCT, which compares 3 treatments: (1) delayed program access: usual diabetes care for 3 months postbaseline followed by access to the full OnTrack Diabetes program; (2) immediate program: full access to the self-guided program from baseline onward; and (3) immediate program plus therapist support via Functional Imagery Training (FIT). Measures are administered at baseline and at 3, 6, and 12 months postbaseline. Primary outcomes are diabetes self-care behaviors (physical activity participation, diet, medication adherence, and blood glucose monitoring), glycated hemoglobin A1c (HbA1c) level, and diabetes-specific distress. Secondary outcomes are depression, anxiety, self-efficacy and adherence, and quality of life. Exposure data in terms of program uptake, use, time on each page, and program completion, as well as implementation feasibility will be conducted. RESULTS: This trial is currently underway with funding support from the Wesley Research Institute in Brisbane, Australia. CONCLUSIONS: This is the first known trial of an automated, self-guided, Web-based support program that uses a holistic approach in targeting both type 2 diabetes self-management and dysphoria. Findings will inform the feasibility of implementing such a program on an ongoing basis, including in rural and regional locations. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registration number: ACTRN12612000620820; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000620820 (Archived by WebCite at http://www.webcitation.org/6a3BeXC5m).

Mitii™ ABI: study protocol of a randomised controlled trial of a web-based multi-modal training program for children and adolescents with an Acquired Brain Injury (ABI).

BACKGROUND: Acquired brain injury (ABI) refers to multiple disabilities arising from damage to the brain acquired after birth. Children with an ABI may experience physical, cognitive, social and emotional-behavioural impairments which can impact their ability to participate in activities of daily living (ADL). Recent developments in technology have led to the emergence of internet-delivered therapy programs. "Move it to improve it" (Mitii™) is a web-based multi-modal therapy that comprises upper limb (UL) and cognitive training within the context of meaningful physical activity. The proposed study aims to compare the efficacy of Mitii™ to usual care to improve ADL motor and processing skills, gross motor capacity, UL and executive functioning in a randomised waitlist controlled trial. METHODS/DESIGN: Sixty independently ambulant children (30 in each group) at least 12 months post ABI will be recruited to participate in this trial. Children will be matched in pairs at baseline and randomly allocated to receive either 20 weeks of Mitii™ training (30 min per day, six days a week, with a potential total dose of 60 h) immediately, or be waitlisted for 20 weeks. Outcomes will be assessed at baseline, immediately post-intervention and at 20 weeks post-intervention. The primary outcomes will be the Assessment of Motor and Process Skills and 30 s repetition maximum of functional strength exercises (sit-to-stand, step-ups and half kneel to stand). Measures of body structure and functions, activity, participation and quality of life will assess the efficacy of Mitii™ across all domains of the International Classification of Functioning, Disability and Health framework. A subset of children will undertake three tesla (3T) magnetic resonance imaging scans to evaluate functional neurovascular changes, structural imaging, diffusion imaging and resting state functional connectivity before and after intervention. DISCUSSION: Mitii™ provides an alternative approach to deliver intensive therapy for children with an ABI in the convenience of the home environment. If Mitii™ is found to be effective, it may offer an accessible and inexpensive intervention option to increase therapy dose. TRIAL REGISTRATION: ANZCTR12613000403730.

A cost-minimisation analysis comparing photoselective vaporisation (PVP) and transurethral resection of the prostate (TURP) for the management of symptomatic benign prostatic hyperplasia (BPH) in Queensland, Australia.

OBJECTIVES: To compare the costs of photoselective vaporisation (PVP) and transurethral resection of the prostate (TURP) for management of symptomatic benign prostatic hyperplasia (BPH) from the perspective of a Queensland public hospital provider. PATIENTS AND METHODS: A decision-analytic model was used to compare the costs of PVP and TURP. Cost inputs were sourced from an audit of patients undergoing PVP or TURP across three hospitals. The probability of re-intervention was obtained from secondary literature sources. Probabilistic and multi-way sensitivity analyses were used to account for uncertainty and test the impact of varying key assumptions. RESULTS: In the base case analysis, which included equipment, training and re-intervention costs, PVP was AU$ 739 (95% credible interval [CrI] -12 187 to 14 516) more costly per patient than TURP. The estimate was most sensitive to changes in procedural costs, fibre costs and the probability of re-intervention. Sensitivity analyses based on data from the most favourable site or excluding equipment and training costs reduced the point estimate to favour PVP (incremental cost AU$ -684, 95% CrI -8319 to 5796 and AU$ -100, 95% CrI -13 026 to 13 678, respectively). However, CrIs were wide for all analyses. CONCLUSIONS: In this cost minimisation analysis, there was no significant cost difference between PVP and TURP, after accounting for equipment, training and re-intervention costs. However, PVP was associated with a shorter length of stay and lower procedural costs during audit, indicating PVP potentially provides comparatively good value for money once the technology is established.

Study protocol for reducing childbirth fear: a midwife-led psycho-education intervention.

BACKGROUND: Childbirth fear has received considerable attention in Scandinavian countries, and the United Kingdom, but not in Australia. For first-time mothers, fear is often linked to a perceived lack of control and disbelief in the body's ability to give birth safely, whereas multiparous women may be fearful as a result of previous negative and/or traumatic birth experiences. There have been few well-designed intervention studies that test interventions to address women's childbirth fear, support normal birth, and diminish the possibility of a negative birth experience. METHODS/DESIGN: Pregnant women in their second trimester of pregnancy will be recruited and screened from antenatal clinics in Queensland, Australia. Women reporting high childbirth fear will be randomly allocated to the intervention or control group. The psycho-educational intervention is offered by midwives over the telephone at 24 and 34 weeks of pregnancy. The intervention aims to review birth expectations, work through distressing elements of childbirth, discuss strategies to develop support networks, affirm that negative childbirth events can be managed and develop a birth plan. Women in the control group will receive standard care offered by the public funded maternity services in Australia. All women will receive an information booklet on childbirth choices. Data will be collected at recruitment during the second trimester, 36 weeks of pregnancy, and 4-6 weeks after birth. DISCUSSION: This study aims to test the efficacy of a brief, midwife-led psycho-education counselling (known as BELIEF: Birth Emotions - Looking to Improve Expectant Fear) to reduce women's childbirth fear. 1) Relative to controls, women receiving BELIEF will report lower levels of childbirth fear at term; 2) less decisional conflict; 3) less depressive symptoms; 4) better childbirth self-efficacy; and 5) improved health and obstetric outcomes. TRIAL REGISTRATION: Australian New Zealand Controlled Trials Registry ACTRN12612000526875.

Uptake of Medicare chronic disease management incentives - a study into service providers' perspectives.

BACKGROUND: Chronic disease is responsible for 80% of the burden of disease in Australia. The Australian Government Medicare Benefits Schedule (MBS) provides incentives through specific Medicare items to optimise chronic disease management (CDM), yet little is known about factors that influence their uptake. METHODS: Exploratory qualitative research was used, which incorporated focus groups and interviews with 26 staff from nine general practices in southeast Queensland, together with review of practice-specific data on CDM income. Content analysis of qualitative data was undertaken to identify barriers, enablers and service models associated with MBS CDM item uptake. Triangulation of methods and data sources facilitated confirmation of findings. RESULTS: Time pressures and unreliable MBS information were common barriers to uptake for general practitioners. Employing a nurse, team-based approaches, recall systems and using only selected MBS CDM item numbers were associated with best uptake. CONCLUSION: Improved systems within general practice and Medicare may increase the uptake of MBS CDM item numbers.

A non-randomised trial investigating the cost-effectiveness of Midwifery Group Practice compared with standard maternity care arrangements in one Australian hospital.

OBJECTIVE: to compare cost-effectiveness of two models of maternity service delivery: Midwifery Group Practice (MGP) at a birth centre and standard care (SC). DESIGN: a prospective non-randomised trial. SETTING: an Australian metropolitan hospital. METHOD: women at 36 weeks gestation were approached in the birth centre or hospital antenatal clinics between March and December 2008. Of 170 consecutive women who met birth centre eligibility criteria, 70% (n=119) were recruited to the study. Women (MGP n=52 or standard care n=50) were followed through to 6 weeks postpartum. Publically funded care costs were collected from women's diaries, handheld pregnancy health records, medical records and the hospital accounting system. MAIN OUTCOME MEASURES: health-care costs to the hospital and government. ANALYSIS: generalised linear models with covariates of age, nulliparity, private health insurance (yes/no) and household income category. FINDINGS: women receiving MGP care were less likely to experience induction of labour, required fewer antenatal visits, received more postnatal care, and neonates were less likely to be admitted to special care nursery than those receiving standard care. Statistically significant lower costs were found for women and babies receiving MGP care compared with women receiving standard care during pregnancy, labour and birth and postpartum to 6 weeks. MGP resulted in lower costs for the hospital ($AUD4,696 vs. $AUD5,521 p<0.001) and the government ($AUD4,722 vs. $AUD5,641 p<0.001). When baby costs were excluded MGP care remained statistically significantly cheaper than standard care. CONCLUSION: for women at low-risk of birth complications, Midwifery Group Practice was cost effective, and women experienced fewer obstetric interventions compared with standard maternity care. The evidence suggests Midwifery Group Practice is safe and economically viable.

Prolotherapy injections and eccentric loading exercises for painful Achilles tendinosis: a randomised trial.

OBJECTIVE: To compare the effectiveness and cost-effectiveness of eccentric loading exercises (ELE) with prolotherapy injections used singly and in combination for painful Achilles tendinosis. DESIGN: A single-blinded randomised clinical trial. The primary outcome measure was the VISA-A questionnaire with a minimum clinically important change (MCIC) of 20 points. SETTING: Five Australian primary care centres. PARTICIPANTS: 43 patients with painful mid-portion Achilles tendinosis commenced and 40 completed treatment protocols. INTERVENTIONS: Participants were randomised to a 12-week program of ELE (n=15), or prolotherapy injections of hypertonic glucose with lignocaine alongside the affected tendon (n=14) or combined treatment (n=14). MAIN OUTCOME MEASUREMENTS: VISA-A, pain, stiffness and limitation of activity scores; treatment costs. RESULTS: At 12 months, proportions achieving the MCIC for VISA-A were 73% for ELE, 79% for prolotherapy and 86% for combined treatment. Mean (95% CI) increases in VISA-A scores at 12 months were 23.7 (15.6 to 31.9) for ELE, 27.5 (12.8 to 42.2) for prolotherapy and 41.1 (29.3 to 52.9) for combined treatment. At 6 weeks and 12 months, these increases were significantly less for ELE than for combined treatment. Compared with ELE, reductions in stiffness and limitation of activity occurred earlier with prolotherapy and reductions in pain, stiffness and limitation of activity occurred earlier with combined treatment. Combined treatment had the lowest incremental cost per additional responder ($A1539) compared with ELE. CONCLUSIONS: For Achilles tendinosis, prolotherapy and particularly ELE combined with prolotherapy give more rapid improvements in symptoms than ELE alone but long-term VISA-A scores are similar. TRIAL REGISTRATION NUMBER: ACTRN: 12606000179538.