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Background: Pacific people living in New Zealand, Australia, United States, and the Pacific region continue to experience a disproportionately high burden of long-term conditions, making culturally contextualised behaviour change interventions a priority. The primary aim of this study was to describe the characteristics of behaviour change interventions designed to improve health and effect health behaviour change among Pacific people.Methods: Electronic searches were carried out on OVID Medline, PsycINFO, PubMed, Embase and SCOPUS databases (initial search January 2019 and updated in January 2020) for studies describing an intervention designed to change health behaviour(s) among Pacific people. Titles and abstracts of 5699 papers were screened; 201 papers were then independently assessed. A review of full text was carried out by three of the authors resulting in 208 being included in the final review. Twenty-seven studies were included, published in six countries between 1996 and 2020.Results: Important characteristics in the interventions included meaningful partnerships with Pacific communities using community-based participatory research and ensuring interventions were culturally anchored and centred on collectivism using family or social support. Most interventions used social cognitive theory, followed by popular behaviour change techniques instruction on how to perform a behaviour and social support (unspecified). Negotiating the spaces between Eurocentric behaviour change constructs and Pacific worldviews was simplified using Pacific facilitators and talanoa. This relational approach provided an essential link between academia and Pacific communities.Conclusions: This systematic search and narrative synthesis provides new and important insights into potential elements and components when designing behaviour change interventions for Pacific people. The paucity of literature available outside of the United States highlights further research is required to reflect Pacific communities living in New Zealand, Australia, and the Pacific region. Future research needs to invest in building research capacity within Pacific communities, centering self-determining research agendas and findings to be led and owned by Pacific communities. [ABSTRACT FROM AUTHOR]

Background: Lone parents and their children experience higher than average levels of adverse health and social outcomes, much of which are explained by high rates of poverty. Many high income countries have attempted to address high poverty rates by introducing employment requirements for lone parents in receipt of welfare benefits. However, there is evidence that employment may not reduce poverty or improve the health of lone parents and their children.Methods: We conducted a systematic review of qualitative studies reporting lone parents' accounts of participation in welfare to work (WtW), to identify explanations and possible mechanisms for the impacts of WtW on health and wellbeing. Twenty one bibliographic databases were searched. Two reviewers independently screened references and assessed study quality. Studies from any high income country that met the criteria of focussing on lone parents, mandatory WtW interventions, and health or wellbeing were included. Thematic synthesis was used to investigate analytic themes between studies.Results: Screening of the 4703 identified papers and quality assessment resulted in the inclusion of 16 qualitative studies of WtW in five high income countries, USA, Canada, UK, Australia, and New Zealand, covering a variety of welfare regimes. Our synthesis found that WtW requirements often conflicted with child care responsibilities. Available employment was often poorly paid and precarious. Adverse health impacts, such as increased stress, fatigue, and depression were commonly reported, though employment and appropriate training was linked to increased self-worth for some. WtW appeared to influence health through the pathways of conflict and control, analytical themes which emerged during synthesis. WtW reduced control over the nature of employment and care of children. Access to social support allowed some lone parents to manage the conflict associated with employment, and to increase control over their circumstances, with potentially beneficial health impacts.Conclusion: WtW can result in increased conflict and reduced control, which may lead to negative impacts on mental health. Availability of social support may mediate the negative health impacts of WtW. [ABSTRACT FROM AUTHOR]

Background: Waiting lists for treatment are common in outpatient and community services, Existing methods for managing access and triage to these services can lead to inequities in service delivery, inefficiencies and divert resources from frontline care. Evidence from two controlled studies indicates that an alternative to the traditional "waitlist and triage" model known as STAT (Specific Timely Appointments for Triage) may be successful in reducing waiting times without adversely affecting other aspects of patient care. This trial aims to test whether the model is cost effective in reducing waiting time across multiple services, and to measure the impact on service provision, health-related quality of life and patient satisfaction.Methods/design: A stepped wedge cluster randomised controlled trial has been designed to evaluate the impact of the STAT model in 8 community health and outpatient services. The primary outcome will be waiting time from referral to first appointment. Secondary outcomes will be nature and quantity of service received (collected from all patients attending the service during the study period and health-related quality of life (AQOL-8D), patient satisfaction, health care utilisation and cost data (collected from a subgroup of patients at initial assessment and after 12 weeks). Data will be analysed with a multiple multi-level random-effects regression model that allows for cluster effects. An economic evaluation will be undertaken alongside the clinical trial.Discussion: This paper outlines the study protocol for a fully powered prospective stepped wedge cluster randomised controlled trial (SWCRCT) to establish whether the STAT model of access and triage can reduce waiting times applied across multiple settings, without increasing health service costs or adversely impacting on other aspects of patient care. If successful, it will provide evidence for the effectiveness of a practical model of access that can substantially reduce waiting time for outpatient and community services with subsequent benefits for both efficiency of health systems and patient care.Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN12615001016527 . Approved 15/9/2015. [ABSTRACT FROM AUTHOR]

Background: Drowning is a significant public health issue, with females accounting for one third of global drowning deaths. The rate of female drowning has not decreased within high-income countries and presentations to hospital have increased. This scoping review aimed to explore adult female unintentional drowning, including risk factors, clinical treatment and outcomes of females hospitalised for drowning.Methods: A systematic search of the literature following the PRISMA-ScR framework was undertaken. The databases OVID MEDLINE, Embase, CINAHL, OVID Emcare, Web of Science, Informit and Scopus were accessed. Study locations of focus were Australia, Canada, New Zealand, the United Kingdom, and the United States. Studies from January 2003 to April 2019 were included. The quality of evidence of included studies was assessed using GRADE guidelines.Results: The final search results included 14 studies from Australia (n = 4), Canada (n = 1), New Zealand (n = 1), United States (n = 6), United Kingdom (n = 1), and one study reporting data from both Australia and United States. Nine studies reported risk factors for female drowning including age, with the proportion of female drowning incidence increasing with age. Although females are now engaging in risk-taking behaviours associated with drowning that are similar to males, such as consuming alcohol and swimming in unsafe locations, their exposure to risky situations and ways they assess risk, differ. Females are more likely to drown from accidental entry into water, such as in a vehicle during a flood or fall into water. This review found no evidence on the clinical treatment provided to females in hospital after a drowning incident, and only a small number of studies reported the clinical outcomes of females, with inconsistent results (some studies reported better and some no difference in clinical outcomes among females).Conclusion: Adult females are a group vulnerable to drowning, that have lacked attention. There was no single study found which focused solely on female drowning. There is a need for further research to explore female risk factors, the clinical treatment and outcomes of females hospitalised for drowning. This will not only save the lives of females, but also contribute to an overall reduction in drowning. [ABSTRACT FROM AUTHOR]

Background: Globally, bronchiectasis (BE) unrelated to cystic fibrosis (CF) is recognized as a major cause of respiratory morbidity, mortality, and healthcare utilization. Children with BE regularly experience exacerbations of their condition resulting in frequent hospitalizations and decreased health-related quality of life (HR-QoL). Guidelines for the treatment and management of BE call for regular exercise as a means of improving aerobic fitness and HR-QoL. Moreover, research in adults with BE has shown that exercise can reduce the frequency of exacerbations, a potent predictor of future lung function decline and respiratory morbidity. Yet, to date, the health benefits resulting from therapeutic exercise have not been investigated in children with BE. The BREATH, Bronchiectasis - Exercise as Therapy, trial will test the efficacy of a novel 8-week, play-based therapeutic exercise program to reduce the frequency of acute exacerbations over 12 months in children with BE (aged ≥ 4 and < 13 years). Secondary aims are to determine the cost-effectiveness of the intervention and assess the program's impact on aerobic fitness, fundamental movement skill (FMS) proficiency, habitual physical activity, HR-QoL, and lung function.Methods: This multi-center, observer-blinded, parallel-group (1:1 allocation), randomized controlled trial (RCT) will be conducted at three sites. One hundred and seventy-four children ≥ 4 and < 13 years of age with BE will be randomized to a developmentally appropriate, play-based therapeutic exercise program (eight, 60-min weekly sessions, supplemented by a home-based program) or usual care. After completing the baseline assessments, the number of exacerbations and secondary outcomes will be assessed immediately post-intervention, after 6 months of follow-up, and after 12 months of follow-up. Monthly, parental contact and medical review will document acute respiratory exacerbations and parameters for cost-effectiveness outcomes.Discussion: The BREATH trial is the first fully powered RCT to test the effects of a therapeutic exercise on exacerbation frequency, fitness, movement competence, and HR-QoL in children with bronchiectasis. By implementing a developmentally appropriate, play-based exercise program tailored to the individual needs of children with bronchiectasis, the results have the potential for a major paradigm shift in the way in which therapeutic exercise is prescribed and implemented in children with chronic respiratory conditions. The exercise program can be readily translated. It does not require expensive equipment and can be delivered in a variety of settings, including the participant's home. The program has strong potential for translation to other pediatric patient groups with similar needs for exercise therapy, including those with obesity, childhood cancers, and neurological conditions such as cerebral palsy.Trial Registration: Australian and New Zealand Clinical Trials Register (ANZCTR) ACTRN12619001008112. [ABSTRACT FROM AUTHOR]

Background: Perioperative medicine services for older surgical patients are being developed across several countries. This qualitative study aims to explore geriatricians' perspectives on challenges and opportunities for developing and delivering integrated geriatrics perioperative medicine services.Methods: A qualitative phenomenological semi-structured interview design. All geriatric medicine departments in acute public hospitals across Australia and New Zealand (n = 81) were approached. Interviews were conducted with 38 geriatricians. Data were analysed thematically using a framework approach.Results: Geriatricians identified several system level barriers to developing geriatrics perioperative medicine services. These included lack of funding for staffing, encroaching on existing consultative services, and competing clinical priorities. The key barrier at the healthcare professional level was the current lack of clarity of roles within the perioperative care team. Key facilitators were perceived unmet patient needs, existing support for geriatrician involvement from surgical and anaesthetic colleagues, and the unique skills geriatricians can bring to perioperative care. Despite reporting barriers, geriatricians are contemplating and implementing integrated proactive perioperative medicine services. Geriatricians identified a need to support other specialties gain clinical experience in geriatric medicine and called for pragmatic research to inform service development.Conclusions: Geriatricians perceive several challenges at the system and healthcare professional levels that are impacting current development of geriatrics perioperative medicine services. Yet their strong belief that patient needs can be met with their specialty skills and their high regard for team-based care, has created opportunities to implement innovative multidisciplinary models of care for older surgical patients. The barriers and evidence gaps highlighted in this study may be addressed by qualitative and implementation science research. Future work in this area may include application of patient-reported measures and qualitative research with patients to inform patient-centred perioperative care. [ABSTRACT FROM AUTHOR]

Background: Interstitial Lung Disease (ILD) is a group of respiratory conditions affecting the lung interstitium often associated with progressive respiratory failure. There is increasing recognition of the need for improved epidemiological data to help determine best practice and improve standardisation of care. The Australasian ILD Registry (AILDR) is a bi-national registry of patients with all ILD subtypes designed to establish a clinically meaningful database reflecting real world practice in Australasia with an objective to improve diagnostic and treatment pathways through research and collaboration.Methods: AILDR is a prospective observational registry recruiting patients attending ILD clinics at centres around Australia and New Zealand. Core and non-core data are stored on a secure server. The pilot phase was launched in 2016 consisting of four sites in Australia. Currently in its second phase a further 16 sites have been recruited, including three in New Zealand.Results: A total of 1061 participants were consented during the pilot phase. Baseline data demonstrated a mean age 68.3 ± 12.5 (SD) years, mean FVC (%predicted) 79.1 ± 20.4 (SD), mean DLCO (%predicted) 58.5 ± 17.9 (SD) and nadir exertional SpO2 (%) 91 ± 6.9 (SD). Idiopathic pulmonary fibrosis (31%) and connective-tissue disease related ILD (21.7%) were the two most common subtypes. Baseline demographics and physiology were not significantly different across the four centres.Conclusion: AILDR is an important clinical and research tool providing a platform for epidemiological data that will prove essential in promoting understanding of a rare cohort of lung disease and provide foundations for our aspiration to standardise investigation and treatment pathways of ILD across Australasia. [ABSTRACT FROM AUTHOR]

Background: Physician migration has been gaining attention worldwide. In Germany, physician migration became a topic of interest in the context of the discussion about a shortage of physicians, for which one contributing factor may be physicians leaving the country. However, there is a lack of literature on "push" factors causing German physicians to leave. The present study seeks to provide current data in an effort to promote the identification of "push" factors motivating German physicians to emigrate.Methods: In a cross-sectional survey, all physicians ≤40 years of age registered with the State Chamber of Physicians of Saxony, Germany (n = 5956) were sent a paper-pencil questionnaire examining socio-demographics, job satisfaction, the wish to emigrate, and the likelihood of moving abroad in the near future. Variables associated with the wish to emigrate were assessed with multivariate logistic regression models.Results: Approximately 30% of participants wished to emigrate. The favourite destination countries were Switzerland, Scandinavian countries, and Australia or New Zealand. Of participants wishing to emigrate, approximately 52% thought it likely to emigrate for a limited, and 15% for an unlimited period of time. Participants with the wish to emigrate were significantly less satisfied with their job situation as compared to physicians without the wish to emigrate, the one exception being their "relationship with patients". The three aspects with the highest difference in satisfaction were the overall work situation, followed by work load, and time for family, friends, and leisure activities. Being a woman, being in a relationship, and having children were associated with a lower chance for wishing to emigrate. Higher satisfaction with the factors "work load", "patient care", and "structural aspects" was also associated with a lower chance for wishing to emigrate.Conclusions: Emigration seems to be a viable option for at least a subset of physicians. Preventive measures should address modifiable determinants associated with an increased chance for wishing to emigrate, such as job satisfaction. Especially satisfaction with the factor "work load" seems to play a crucial role as a "push" factor for physician emigration. [ABSTRACT FROM AUTHOR]

Background: Levels of sitting among adolescents are high, especially during the school day. The acute cognitive and health consequences associated with prolonged sitting are poorly understood in adolescents. This randomized crossover design study examined the acute effects of a simulated school day with reduced sitting or usual sitting on adolescents' cognitive function and cardiometabolic biomarkers.Methods: Eighteen healthy school aged adolescents were recruited from the community to the study (11 males; 7 females; mean age [SD] = 13.5 ± 0.9 years). Two protocols were developed to simulate an adolescent school day, the amount of time spent sitting was manipulated reflecting: a 'typical' day (65% of the time spent sitting with two sitting bouts sitting >20 min) and a 'reduced sitting' day (adolescents sat for 50% less time with no bouts of sitting >20 mins). The order that participants were exposed to each condition was randomized (via random number generator). Participants were not fully blinded as they could observe the difference between conditions. Energy intake and moderate to vigorous physical activity (MVPA) were standardized for both conditions and monitored for 48 h post-condition for compensatory effects. Cognitive (working memory) and cardiometabolic outcomes (lipids, glucose, insulin, IL-6, apo-A1, apo-B, blood pressure,) were assessed pre and post for both conditions, BMI and body fat were assessed on the morning of the intervention. Data were analyzed using linear mixed models. Standardised effect sizes were calculated.Results: Compared with the typical school day, the reduced sitting day demonstrated significant positive effects for apoB/apoA-1 ratio (adjusted difference ± SD) -0.02 ± 0.03; P = 0.03; effect size [Cohen's d] = -0.67. Findings for total cholesterol -0.19 ± 0.27; P = 0.28; d = -0.71; HDL cholesterol -0.23 ± 0.50; P = 0.12 d = -0.66; and total cholesterol/HDL ratio 0.25 ± 0.53; P = 0.25; d = 0.51 and for cognition 0.64 ± 0.15; P = 0.15; d = 0.54 were non-significant. There were no compensatory changes in participant energy expenditure or energy intake for 48 h post intervention.Conclusion: Reducing school day sitting time in adolescents' resulted in significant improvements in apoB/apoA-1 ratio with medium effect sizes for total cholesterol, HDL cholesterol and total cholesterol/HDL ratio. Cognitive function results showed the equivalent of a 6 month improvement in effective mental-attentional capacity.Trial Registration: The trial was registered as a clinical trial with the Australian and New Zealand Clinical Trials Registry ( ACTRN12614001064695 ) on the 3rd of October 2014 - registered retrospectively. [ABSTRACT FROM AUTHOR]

There is extensive health and public health literature on the 'evidence-policy gap', exploring the frustrating experiences of scientists trying to secure a response to the problems and solutions they raise and identifying the need for better evidence to reduce policymaker uncertainty. We offer a new perspective by using policy theory to propose research with greater impact, identifying the need to use persuasion to reduce ambiguity, and to adapt to multi-level policymaking systems.We identify insights from secondary data, namely systematic reviews, critical analysis and policy theories relevant to evidence-based policymaking. The studies are drawn primarily from countries such as the United States, United Kingdom, Canada, Australia and New Zealand. We combine empirical and normative elements to identify the ways in which scientists can, do and could influence policy.We identify two important dilemmas, for scientists and researchers, that arise from our initial advice. First, effective actors combine evidence with manipulative emotional appeals to influence the policy agenda - should scientists do the same, or would the reputational costs outweigh the policy benefits? Second, when adapting to multi-level policymaking, should scientists prioritise 'evidence-based' policymaking above other factors? The latter includes governance principles such the 'co-production' of policy between local public bodies, interest groups and service users. This process may be based primarily on values and involve actors with no commitment to a hierarchy of evidence.We conclude that successful engagement in 'evidence-based policymaking' requires pragmatism, combining scientific evidence with governance principles, and persuasion to translate complex evidence into simple stories. To maximise the use of scientific evidence in health and public health policy, researchers should recognise the tendency of policymakers to base judgements on their beliefs, and shortcuts based on their emotions and familiarity with information; learn 'where the action is', and be prepared to engage in long-term strategies to be able to influence policy; and, in both cases, decide how far you are willing to go to persuade policymakers to act and secure a hierarchy of evidence underpinning policy. These are value-driven and political, not just 'evidence-based', choices. [ABSTRACT FROM AUTHOR]

Background: IQ deficits are linked to even mild obstructive sleep apnoea (OSA) in children. Although OSA is commonly first diagnosed in the pre-school age group, a randomised trial is still needed to assess IQ outcomes after adenotonsillectomy in the pre-school age-group. This randomised control trial (RCT) will primarily determine whether adenotonsillectomy improves IQ compared to no adenotonsillectomy after 12 months, in preschool (3-5 year-old) children with mild to moderate OSA.Methods: This protocol is for an ongoing multi-centred RCT with a recruitment target of 210 subjects (105 in each arm). Children age 3-5 years with symptoms of OSA, are recruited through doctor referral, at the point of referral to the Ear Nose and Throat (ENT) services. Screening is initially with a questionnaire (Paediatric Sleep Questionnaire, PSQ) for symptoms of obstructive sleep apnoea (OSA). Where questionnaires are positive (suggestive of OSA) and ENT surgeons recommend them for adenotonsillectomy, they are invited to participate in POSTA. Baseline testing includes neurocognitive testing (IQ and psychometric evaluation with the neuropsychologist blinded to randomisation) and overnight polysomnography (PSG). Where the Obstructive Apnoea-Hypopnea Index (OAHI) from the PSG is <10/h per hour, consent for randomisation is sought; children with severe OSA (OAHI ≥ 10/h) are sent for immediate treatment and excluded from the study. After consent is obtained, participants are randomised to early surgery (within 2 months) or to surgery after a usual wait time of 12 months. Follow-up studies include repeat neurocognitive testing and PSG at 12 (with the waiting list group studied before their surgery) and 24 months after randomisation. Analysis will be by intention to treat. The primary outcome is IQ at 12 months' follow-up.Discussion: If IQ deficits associated with OSA are reversible 12 months after adenotonsillectomy compared to controls, future clinical practice advise would be to undertake early surgery in young children with OSA. The study could provide data on whether a window of opportunity exists for reversing IQ deficits linked to OSA in the pre-school age-group.Trial Registration: Australian and New Zealand Clinical Trials Registration Number ACTRN12611000021976 . [ABSTRACT FROM AUTHOR]

Background: The possible therapeutic impact of dietary changes on existing mental illness is largely unknown. Using a randomised controlled trial design, we aimed to investigate the efficacy of a dietary improvement program for the treatment of major depressive episodes.Methods: 'SMILES' was a 12-week, parallel-group, single blind, randomised controlled trial of an adjunctive dietary intervention in the treatment of moderate to severe depression. The intervention consisted of seven individual nutritional consulting sessions delivered by a clinical dietician. The control condition comprised a social support protocol to the same visit schedule and length. Depression symptomatology was the primary endpoint, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS) at 12 weeks. Secondary outcomes included remission and change of symptoms, mood and anxiety. Analyses utilised a likelihood-based mixed-effects model repeated measures (MMRM) approach. The robustness of estimates was investigated through sensitivity analyses.Results: We assessed 166 individuals for eligibility, of whom 67 were enrolled (diet intervention, n = 33; control, n = 34). Of these, 55 were utilising some form of therapy: 21 were using psychotherapy and pharmacotherapy combined; 9 were using exclusively psychotherapy; and 25 were using only pharmacotherapy. There were 31 in the diet support group and 25 in the social support control group who had complete data at 12 weeks. The dietary support group demonstrated significantly greater improvement between baseline and 12 weeks on the MADRS than the social support control group, t(60.7) = 4.38, p < 0.001, Cohen's d = -1.16. Remission, defined as a MADRS score <10, was achieved for 32.3% (n = 10) and 8.0% (n = 2) of the intervention and control groups, respectively (χ 2 (1) = 4.84, p = 0.028); number needed to treat (NNT) based on remission scores was 4.1 (95% CI of NNT 2.3-27.8). A sensitivity analysis, testing departures from the missing at random (MAR) assumption for dropouts, indicated that the impact of the intervention was robust to violations of MAR assumptions.Conclusions: These results indicate that dietary improvement may provide an efficacious and accessible treatment strategy for the management of this highly prevalent mental disorder, the benefits of which could extend to the management of common co-morbidities.Trial Registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000251820 . Registered on 29 February 2012. [ABSTRACT FROM AUTHOR]

Background: Low back pain is a common and costly condition internationally. There is high need to identify effective and economically efficient means for managing this problem. This study aimed to explore the cost-effectiveness of a novel motion-sensor biofeedback treatment approach in addition to guidelines-based care compared to guidelines-based care alone, from a societal perspective over a 12 month time horizon.Method: This was an incremental cost-effectiveness analysis conducted concurrently with a pilot, cluster randomized controlled trial. Health care resource use was collected using daily diaries and patient-self report at 3, 6 and 12 month follow-up assessments. Productivity was measured using industry classifications and participant self-reporting of ability to do their normal work with their present pain. Clinical effect was measured using the Patient Global Impression of Change measured at the 12 month follow-up assessment. Data were compared between groups using linear regression clustered by recruitment site. Bootstrap resampling was used to generate a visual representation of the 95% confidence interval for the incremental cost-effectiveness estimate. Two, one-way sensitivity analyses were undertaken to examine the robustness of findings to key assumptions.Result: There were n = 38 participants in the intervention group who completed the 12 month assessment and n = 45 in the control. The intervention group had greater use of trial-related medical and therapy resources [$477 per participant (95% CI: $447, $508)], but lower use of non-trial medical and therapy resources [$-53 per participant (95% CI: $-105, $-0)], and a greater improvement in productivity [$-5123 per participant (95% CI: $-10,174, $-72)]. Overall, the intervention dominated with a saving of $478,100 and an additional 41 participants self-rating as being very or much improved compared to the control. There was >99% confidence in this finding of dominance in both the primary and sensitivity analyses.Conclusions: The motion-sensor biofeedback treatment approach in addition to guidelines- based care appears to be both more clinically effective and economically efficient than guidelines- based care alone. This approach appears to be a viable means to manage low back pain and further research in this area should be a priority.Trial Registration: The randomised trial this research was based upon was prospectively registered on March 25th 2009 with the Australian New Zealand Clinical Trials Registry: ACTRN12609000157279 . [ABSTRACT FROM AUTHOR]

Background: Despite substantial investment in detection, early intervention and evidence-based treatments, current management strategies for diabetes-associated retinopathy and cardiovascular disease are largely based on real-time and face-to-face approaches. There are limited data re telehealth facilitation in type 2 diabetes management. Therefore, we aim to investigate efficacy of telehealth facilitation of diabetes and cardiovascular disease care in high-risk vulnerable Aboriginal and Torres Strait Islanders in remote/very remote Australia.Methods: Using a pre-post intervention design, 600 Indigenous Australians with type 2 diabetes will be recruited from three primary-care health-services in the Northern Territory. Diabetes status will be based on clinical records. There will be four technological interventions: 1. Baseline retinal imaging [as a real-time patient education/engagement tool and telehealth screening strategy]. 2. A lifestyle survey tool administered at ≈ 6-months. 3. At ≈ 6- and 18-months, an electronic cardiovascular disease and diabetes decision-support tool based on current guidelines in the Standard Treatment Manual of the Central Australian Rural Practitioner's Association to generate clinical recommendations. 4. Mobile tablet technology developed to enhance participant engagement in self-management. Data will include: Pre-intervention clinical and encounter-history data, baseline retinopathy status, decision-support and survey data/opportunistic mobile tablet encounter data. The primary outcome is increased participant adherence to clinical appointments, a marker of engagement and self-management. A cost-benefit analysis will be performed.Discussion: Remoteness is a major barrier to provision and uptake of best-practice chronic disease management. Telehealth, beyond videoconferencing of consultations, could facilitate evidence-based management of diabetes and cardiovascular disease in Indigenous Australians and serve as a model for other conditions.Trial Registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN 12616000370404 was retrospectively registered on 22/03/2016. [ABSTRACT FROM AUTHOR]

Background: Recent technological advances provide an alternative yet underutilised opportunity for promoting physical activity in youth. The primary aim of the Raising Awareness of Physical Activity (RAW-PA) Study is to examine the short- and longer-term impact of a wearable activity monitor combined with digital behaviour change resources on adolescents' daily physical activity levels.Methods/design: RAW-PA is a 12 week, multicomponent physical activity intervention that utilises a popular activity tracker (Fitbit® Flex) and supporting digital materials that will be delivered online via social media. The resources target key behaviour change techniques. The intervention structure and components have been informed by participatory research principles. RAW-PA will be evaluated using a cluster randomised controlled trial design with schools as the unit of randomisation. Twelve schools located in Melbourne, Australia, will allocated to either the intervention or wait-list control group. The target sample size is 300 Year 8 adolescents (aged 13-14 years). Participants' moderate- to vigorous-intensity physical activity will be the primary outcome. Survey measures will be completed. Process factors (e.g. feasibility, acceptability/appeal, fidelity) will also be collected.Discussion: To our knowledge, this study will provide some of the first evidence concerning the effect of wearable activity trackers and digital behaviour change resources on adolescents' physical activity levels. This study will provide insights into the use of such technologies for physical activity promotion, which may have a significant impact on health education, promotion, practice and policy.Trial Registration: Australian and New Zealand Clinical Trials Registry No: ACTRN12616000899448 . Date of registration: July 7, 2016. [ABSTRACT FROM AUTHOR]

Background: Parkinson's disease (PD) is the second commonest neurodegenerative disease in developed countries. Current treatment for PD is pharmacologically focused and can have significant side-effects. There is increasing interest in holistic approaches including mindfulness to help manage the challenges associated with living with PD. We hypothesised that there would be an improvement in PD associated function and wellbeing in participants after participating in a 6-week mindfulness-based lifestyle program, and that these improvements would be sustainable at 6 months. Our primary objective was to determine changes in function and wellbeing associated with PD.Methods: An exploratory prospective, mixed-method, randomised control trial incorporating a before and after design with a waitlist control, with an embedded qualitative component was conducted in 2012-2013. Participants included community living adults with disability congruent to H&Y Stage 2 PD, aged 18-75, fluent in spoken and written English and able to attend at least four of six sessions of the program. Participants were randomised to the intervention or wait-list control groups at two locations. All participants in the wait-list control group eventually received the intervention. Two randomisation codes were created for each location. Allocation to the intervention or wait-list control was by random number generation. The program facilitator and participants were blinded to participant data.Results: Group 1 included 35 participants and group 2 (the waitlist control), 37. Data was analysed from 24 (group 1) and 33 (group 2) participants. The intervention group, compared to the waitlist control, showed a small improvement in function and wellbeing associated with PD immediately after the program (t-score = -0.59) and at 6-month post intervention (t-score = -1.42) as reported by the PDQ-39 SI. However this finding was not significant (p = 0.56 and 0.16 respectively). A small yet significant effect size (β = 0.23) in PDQ-39 ADL was reported in group 1 after 6-months post-intervention. This showed a positive improvement in the ADL as reported by group 1 after 6-months (t-score -1.8, p = 0.04). Four secondary measures are reported.Conclusions: Our findings suggest mindfulness-based lifestyle programs have potential to assist participants in managing the ongoing difficulties associated with a neurological condition such as Parkinson's disease. Importantly, our study shows promise for the long term benefits of such programs. Improvements to participant activities in daily living and mindfulness were retained at 6-months post intervention. A more definitive study should be conducted in a larger sample of PD patients to further explore these findings and their impact on reducing stress and anxiety in PD patients.Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12612000440820 , 17(th) April 2012. [ABSTRACT FROM AUTHOR]

Background: Improving vitamin D (25-OHD) status may be an important modifiable factor that could reduce disability severity, fall-rates and mortality associated after hip fracture surgery. Providing a loading-dose post-surgery may overcome limitations in adherence to daily supplementation.Method: In this randomized, double-blind, placebo-controlled trial, 218 adults, aged 65-years or older, requiring hip fracture surgery were assigned to receive a single loading-dose of cholecalciferol (250,000 IU vitamin-D3, the REVITAHIP - Replenishment of Vitamin D in Hip Fracture strategy) or placebo, both receiving daily vitamin-D(800 IU) and calcium (500 mg) for 26-weeks. Outcome measures were 2.4 m gait-velocity, falls, fractures, death (Week-4), 25-OHD levels, quality-of-life measure (EuroQoL) and mortality at weeks-2, 4 and 26.Results: Mean age of 218 participants was 83.9(7.2) years and 77.1 % were women. Baseline mean 25-OHD was 52.7(23.5)nmol/L, with higher levels at Week-2 (73 vs 66 nmol/L; p = .019) and Week-4 (83 vs 75 nmol/L; p = .030) in the Active-group, but not at Week-26. At week-4, there were no differences in 2.4 m gait-velocity (0.42 m/s vs 0.39 m/s, p = .490), fractures (2.7 % vs 2.8 %, p = .964) but Active participants reported less falls (6.3 % vs 21.1 %, χ(2) = 4.327; p = 0.024), with no significant reduction in deaths at week-4 (1 vs 3, p = 0.295), higher percentage reporting 'no pain or discomfort' (96.4 % vs 88.8 %, p = 0.037), and trended for higher EuroQoL-scores (p = 0.092) at week-26. One case of hypercalcemia at week-2 normalised by week-4.Conclusion: Among older people after hip fracture surgery, the REVITAHIP strategy is a safe and low cost method of improving vitamin-D levels, reducing falls and pain levels.Trial Registration: The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry ANZCTRN ACTRN12610000392066 (Date of registration: 14/05/2010). [ABSTRACT FROM AUTHOR]

Background: Action research (AR) and randomized controlled trials (RCTs) are usually considered to be theoretically and practically incompatible. However, we argue that their respective strengths and weaknesses can be complementary. We illustrate our argument from a recent study assessing the effect of telemonitoring on health-related quality of life, self-care, hospital use, costs and the experiences of patients, informal carers and health care professionals in two urban hospital services and one remote rural primary care service in New Zealand.Methods: Data came from authors' observations and field notes of discussions with three groups: the healthcare providers and healthcare consumers who participated in the research, and a group of 17 researchers and collaborators. The consumers had heart failure (Site A, urban), airways disease (Site B, urban), and diabetes (Site C, rural). The research ran from 2008 (project inception) until 2012 (project close-off). Researchers came from a wide range of disciplines. Both RCT and AR methods were recognised from early in the process but often worked in parallel rather than together. In retrospect, we have mapped our observed research processes to the AR cycle characteristics (creation of communicative space, democracy and participation, iterative learning and improvement, emergence, and accommodation of different ways of knowing).Results: We describe the context, conduct and outcomes of the telemonitoring trial, framing the overall process in the language of AR. Although not fully articulated at the time, AR processes made the RCT sensitive to important context, e.g. clinical processes. They resulted in substantive changes to the design and conduct of the RCT, and to interpretation and uptake of findings, e.g. a simpler technology procurement process emerged. Creating a communicative space enabled co-design between the researcher group and collaborators from the provider participant group, and a stronger RCT design.Conclusions: It appears possible to enhance the utility of RCTs by explicitly embedding them in an AR framework to shape stronger RCT design. The AR process and characteristics may enable researchers to evaluate telehealth while enhancing rather than compromising the quality of an RCT, where research results are returned to practice as part of the research process.Trial Registration: Australian New Zealand Clinical Trials Registry, reference ACTRN12610000269033 . [ABSTRACT FROM AUTHOR]

Background: Admission to hospital can lead to persistent deterioration in physical functioning, particularly for the more vulnerable older population. As a result of this physical deterioration, older people who have been recently discharged from hospital may be particularly high users of health and social support services. Quantify usage and costs of services in older adults after hospitalisation and explore the impact of a home-exercise intervention on service usage.Method: The present study was a secondary analysis of data from a randomised controlled trial (ACTRN12607000563460). The trial involved 340 participants aged 60 years and over with recent hospitalisation. Service use and costs were compared between intervention (12 months of home-exercise prescribed in 10 visits from a physiotherapist) and control groups.Results: 33 % of participants were re-admitted to hospital, 100 % consulted a General Medical Practitioner and 63 % used social services. 56 % of costs were associated with hospital admission and 22 % with social services. There was reduction in General Medical Practitioner services provided in the home in the intervention group (IRR 0.23, CI 0.1 to 0.545, p < 0.01) but no significant between-group difference in service use or in costs for other service categories.Conclusion: There appears to be substantial hospital and social service use and costs in this population of older people. No significant impact of a home-based exercise program was evident on service use or costs.Trial Registration: Australian and New Zealand Clinical Trial Registry ACTRN12607000563460 >TrialSearch. [ABSTRACT FROM AUTHOR]

Background: Methicillin-resistant Staphylococcus aureus (MRSA) bacteraemia is a serious infection resulting in 20-50 % 90-day mortality. The limitations of vancomycin, the current standard therapy for MRSA, make treatment difficult. The only other approved drug for treatment of MRSA bacteraemia, daptomycin, has not been shown to be superior to vancomycin. Surprisingly, there has been consistent in-vitro and in-vivo laboratory data demonstrating synergy between vancomycin or daptomycin and an anti-staphylococcal β-lactam antibiotic. There is also growing clinical data to support such combinations, including a recent pilot randomised controlled trial (RCT) that demonstrated a trend towards a reduction in the duration of bacteraemia in patients treated with vancomycin plus flucloxacillin compared to vancomycin alone. Our aim is to determine whether the addition of an anti-staphylococcal penicillin to standard therapy results in improved clinical outcomes in MRSA bacteraemia.Methods/design: We will perform an open-label, parallel-group, randomised (1:1) controlled trial at 29 sites in Australia, New Zealand, Singapore, and Israel. Adults (aged 18 years or older) with MRSA grown from at least one blood culture and able to be randomised within 72 hours of the index blood culture collection will be eligible for inclusion. Participants will be randomised to vancomycin or daptomycin (standard therapy) given intravenously or to standard therapy plus 7 days of an anti-staphylococcal β-lactam (flucloxacillin, cloxacillin, or cefazolin). The primary endpoint will be a composite outcome at 90 days of (1) all-cause mortality, (2) persistent bacteraemia at day 5 or beyond, (3) microbiological relapse, or (4) microbiological treatment failure. The recruitment target of 440 patients is based on an expected failure rate for the primary outcome of 30 % in the control arm and the ability to detect a clinically meaningful absolute decrease of 12.5 %, with a two-sided alpha of 0.05, a power of 80 %, and assuming 10 % of patients will not be evaluable for the primary endpoint.Discussion: Key potential advantages of adding anti-staphylococcal β-lactams to standard therapy for MRSA bacteraemia include their safety profile, low cost, and wide availability.Trial Registration: ClinicalTrials.gov Identifier: NCT02365493 . Registered 24 February 2015. [ABSTRACT FROM AUTHOR]

Background: Meaning in life is a key indicator of subjective well-being and quality of life. Further developments in understanding and enhancing the construct will depend inter alia on the sound measurement thereof. This study is at the forefront of applying modern psychometric techniques to the Meaning in Life Questionnaire, a scale widely used to assess meaning in life.Method: The Rasch rating scale model was applied to the Presence and Search subscales of the Meaning in Life Questionnaire using a sample of 601 adults from South Africa, Australia, and New Zealand.Results: The Presence subscale was insensitive at high levels of presence of meaning while the majority of the respondents fell in that range. Removal of item 9 ("My life has no clear purpose") and collapsing the response categories indicative of low and medium levels of the latent construct significantly improved the subscale's targeting and fit to the Rasch model, resulting in a subscale that exhibited differential item functioning on items 1 ("I understand my life's meaning"), 4 ("My life has a clear sense of purpose"), and 5 ("I have a good sense of what makes my life meaningful") for country, but none for gender, age group, or education level. The Search subscale yielded disordered category threshold calibrations, but after collapsing some of the response categories representing low and medium levels of the target construct, a subscale that demonstrated good fit to the Rasch model, good targeting, and no differential item functioning resulted.Conclusions: In terms of this particular scale, adaptation of the rating scale and removal of item 9 is recommended. Country-level parameter estimates may be needed for items that exhibited differential item functioning. The study also has significant implications for the theory, measurement, and practice of meaning in and quality of life in general. Reasons for and the far-reaching implications of the insensitivity of the Presence subscale for high levels of presence of meaning on, for example, the correlation between meaning in life and indicators of health are contemplated. Further investigation of the construct's nature and measurement, especially at high levels, is indicated. [ABSTRACT FROM AUTHOR]

Background: In 2002, the World Health Organization recommended that the age for starting complementary feeding should be changed from 4 to 6 months of age to 6 months. Although this change in age has generated substantial debate, surprisingly little attention has been paid to whether advice on how to introduce complementary foods should also be changed. It has been proposed that by 6 months of age most infants will have developed sufficient motor skills to be able to feed themselves rather than needing to be spoon-fed by an adult. This has the potential to predispose infants to better growth by fostering better energy self-regulation, however no randomised controlled trials have been conducted to determine the benefits and risks of such a "baby-led" approach to complementary feeding. This is of particular interest given the widespread use of "Baby-Led Weaning" by parents internationally.Methods/design: The Baby-Led Introduction to SolidS (BLISS) study aims to assess the efficacy and acceptability of a modified version of Baby-Led Weaning that has been altered to address potential concerns with iron status, choking and growth faltering. The BLISS study will recruit 200 families from Dunedin, New Zealand, who book into the region's only maternity hospital. Parents will be randomised into an intervention (BLISS) or control group for a 12-month intervention with further follow-up at 24 months of age. Both groups will receive the standard Well Child care provided to all parents in New Zealand. The intervention group will receive additional parent contacts (n = 8) for support and education on BLISS from before birth to 12 months of age. Outcomes of interest include body mass index at 12 months of age (primary outcome), energy self-regulation, iron and zinc intake and status, diet quality, choking, growth faltering and acceptability to parents.Discussion: This study is expected to provide insight into the feasibility of a baby-led approach to complementary feeding and the extent to which this method of feeding affects infant body weight, diet quality and iron and zinc status. Results of this study will provide important information for health care professionals, parents and health policy makers.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12612001133820 . [ABSTRACT FROM AUTHOR]

Background: Membranoproliferative glomerulonephritis (MPGN) is an uncommon cause of end stage kidney disease (ESKD) and the clinical outcomes of patients with MPGN who commence kidney replacement therapy have not been comprehensively studied.Methods: All adult patients with ESKD due to glomerulonephritis commencing kidney replacement therapy in Australia and New Zealand from January 1, 1996 to December 31, 2016 were reviewed. Patients with ESKD due to MPGN were compared to patients with other forms of glomerulonephritis. Patient survival on dialysis and following kidney transplantation, kidney recovery on dialysis, time to transplantation, allograft survival, death-censored allograft survival and disease recurrence post-transplant were compared between the two groups using Kaplan Meier survival curves and Cox proportional hazards regression.Results: Of 56,481 patients included, 456 (0.8%) had MPGN and 12,660 (22.4%) had another form of glomerulonephritis. Five-year patient survival on dialysis and following kidney transplantation were similar between patients with ESKD from MPGN and other forms of glomerulonephritis (Dialysis: 59% vs. 62% p = 0.61; Transplant: 93% vs. 93%, p = 0.49). Compared to patients with other forms of glomerulonephritis, patients with MPGN had significantly poorer 5-year allograft survival (70% vs. 81% respectively, p = 0.02) and death censored allograft survival (74% vs. 87%, respectively; p < 0.01). The risk of disease recurrence was significantly higher in patients with MPGN compared to patients with other glomerulonephritidites (18% vs. 5%; p < 0.01). In patients with MPGN who had allograft loss, patients with MPGN recurrence had a significantly shorter time to allograft loss compared to patients with MPGN who had allograft loss due to any other cause (median time to allograft loss 3.2 years vs. 4.4 years, p < 0.01).Conclusions: Compared with other forms of glomerulonephritis, patients with MPGN experienced comparable rates of survival on dialysis and following kidney transplantation, but significantly higher rates of allograft loss due to disease recurrence. [ABSTRACT FROM AUTHOR]

Background: Physical activity and consuming a healthy diet have clear benefits to the physical and psychosocial health of cancer survivors, with guidelines recognising the importance of these behaviors for cancer survivors. Interventions to promote physical activity and improve dietary behaviors among cancer survivors and carers are needed. The aim of this study was to determine the effects of a group-based, face-to-face multiple health behavior change intervention on behavioral outcomes among cancer survivors of mixed diagnoses and carers.Methods: The Exercise and Nutrition Routine Improving Cancer Health (ENRICH) intervention was evaluated using a two-group pragmatic randomized controlled trial. Cancer survivors and carers (n = 174) were randomly allocated to the face-to-face, group-based intervention (six, theory-based two-hour sessions delivered over 8 weeks targeting healthy eating and physical activity [PA]) or wait-list control (after completion of 20-week data collection). Assessment of the primary outcome (pedometer-assessed mean daily step counts) and secondary outcomes (diet and alcohol intake [Food Frequency Questionnaire], self-reported PA, weight, body mass index, and waist circumference) were assessed at baseline, 8-and 20-weeks.Results: There was a significant difference between the change over time in the intervention group and the control group. At 20 weeks, the intervention group had increased by 478 steps, and the control group had decreased by 1282 steps; this represented an adjusted mean difference of 1761 steps (184 to 3337; P = 0.0028). Significant intervention effects for secondary outcomes, included a half serving increase in vegetable intake (difference 39 g/day; 95 % CI: 12 to 67; P = 0.02), weight loss (kg) (difference -1.5 kg; 95 % CI, -2.6 to -0.3; P = 0.014) and change in body mass index (kg/m(2)) (difference -0.55 kg/m(2); 95 % CI, -0.97 to -0.13; P = 0.012). No significant intervention effects were found for self-reported PA, total sitting time, waist circumference, fruit, energy, fibre, alcohol, meat, or fat consumption.Conclusions: The ENRICH intervention was effective for improving PA, weight, body mass index, and vegetable consumption even with the inclusion of multiple cancer types and carers. As an example of successful research translation, the Cancer Council NSW has subsequently adopted ENRICH as a state-wide program.Trial Registration: Australian New Zealand Clinical Trials Register identifier: ANZCTRN1260901086257. [ABSTRACT FROM AUTHOR]