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Background Otitis media with effusion (OME) is common and occurs at disproportionately higher rates among Indigenous children. Left untreated, OME can negatively affect language, development, learning, and health and wellbeing throughout the life-course. Currently, OME care includes observation for 3 months followed by consideration of surgical ventilation tube insertion. The use of a non-invasive, low-cost nasal balloon autoinflation device has been found beneficial in other populations but has not been investigated among Aboriginal and Torres Strait Islander children. Methods/design This multi-centre, open-label, randomised controlled trial will determine the effectiveness of nasal balloon autoinflation compared to no nasal balloon autoinflation, for the treatment of OME among Aboriginal and Torres Strait Islander children in Australia. Children aged 3–16 years with unilateral or bilateral OME are being recruited from Aboriginal Health Services and the community. The primary outcome is the proportion of children showing tympanometric improvement of OME at 1 month. Improvement is defined as a change from bilateral type B tympanograms to at least one type A or C1 tympanogram, or from unilateral type B tympanogram to type A or C1 tympanogram in the index ear, without deterioration (type A or C1 to type C2, C3, or B tympanogram) in the contralateral ear. A sample size of 340 children (170 in each group) at 1 month will detect an absolute difference of 15% between groups with 80% power at 5% significance. Anticipating a 15% loss to follow-up, 400 children will be randomised. The primary analysis will be by intention to treat. Secondary outcomes include tympanometric changes at 3 and 6 months, hearing at 3 months, ear health-related quality of life (OMQ-14), and cost-effectiveness. A process evaluation including perspectives of parents or carers, health care providers, and researchers on trial implementation will also be undertaken. Discussion INFLATE will answer the important clinical question of whether nasal balloon autoinflation is an effective and acceptable treatment for Aboriginal and Torres Strait Islander children with OME. INFLATE will help fill the evidence gap for safe, low-cost, accessible OME therapies. Trial registration Australia New Zealand Clinical Trials Registry ACTRN12617001652369 . Registered on 22 December 2017. The Australia New Zealand Clinical Trials Registry is a primary registry of the WHO ICTRP network and includes all items from the WHO Trial Registration data set. Retrospective registration.

Depression involves impairments in a range of cognitive and emotional capacities. It is unknown whether these functions can inform medication choice when considered as a composite predictive biomarker. We tested whether behavioral tests, grounded in the neurobiology of cognitive and emotional functions, predict outcome with common antidepressants. Medication-free outpatients with nonpsychotic major depressive disorder (N=1008; 665 completers) were assessed before treatment using 13 computerized tests of psychomotor, executive, memory-attention, processing speed, inhibitory, and emotional functions. Matched healthy controls (N=336) provided a normative reference sample for test performance. Depressed participants were then randomized to escitalopram, sertraline, or venlafaxine-extended release, and were assessed using the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR16) and the 17-item Hamilton Rating Scale for Depression. Given the heterogeneity of depression, analyses were furthermore stratified by pretreatment performance. We then used pattern classification with cross-validation to determine individual patient-level composite predictive biomarkers of antidepressant outcome based on test performance. A subgroup of depressed participants (approximately one-quarter of patients) were found to be impaired across most cognitive tests relative to the healthy norm, from which they could be discriminated with 91% accuracy. These patients with generally impaired cognitive task performance had poorer treatment outcomes. For this impaired subgroup, task performance furthermore predicted remission on the QIDS-SR16 at 72% accuracy specifically following treatment with escitalopram but not the other medications. Therefore, tests of cognitive and emotional functions can form a clinically meaningful composite biomarker that may help drive general treatment outcome prediction for optimal treatment selection in depression, particularly for escitalopram.

Objective This study aimed to examine the association between performance of self‐care activities and patient or disease factors as well as patient activation levels in patients with diabetes and chronic kidney disease (CKD) in Australia. Methods A cross‐sectional study was conducted among adults with diabetes and CKD (eGFR <60 mL/min/1.73m2) who were recruited from renal and diabetes clinics of four tertiary hospitals in Australia. Demographic and clinical data were collected, as well as responses to the Patient Activation Measure (PAM) and the Summary of Diabetes Self‐Care Activities (SDSCA) scale. Regression analyses were performed to determine the relationship between activation and performance of self‐care activities. Results A total of 317 patients (70% men) with a mean age of 66.9 (SD=11.0) years participated. The mean (SD) PAM and composite SDSCA scores were 57.6 (15.5) % (range 0‐100) and 37.3 (11.2) (range 0‐70), respectively. Younger age, being male, advanced stages of CKD and shorter duration of diabetes were associated with lower scores in one or more self‐care components. Patient activation was positively associated with the composite SDSCA score, and in particular the domains of general diet and blood sugar checking (P<.05), but not specific diet, exercising and foot checking. Conclusion In people with diabetes and CKD, a high level of patient activation was positively associated with a higher overall level of self‐care. Our results identify subgroups of people who may benefit from tailored interventions to further improve their health outcomes. Further prospective studies are warranted to confirm present findings.

Background Cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is the leading cause of death and disability globally. A large proportion of mortality occurs in people with prior CHD and effective and scalable strategies are needed to prevent associated deaths and hospitalisations. The aim of this study is to determine if a practice-level collaborative quality improvement program, focused on patients with CHD, reduces the rate of unplanned CVD hospitalisations and major adverse cardiovascular events, and increases the proportion of patients achieving risk factor targets at 24 months. Methods Cluster randomised controlled trial (cRCT) to evaluate the effectiveness of a primary care quality improvement program in 50 primary care practices (n~ 10,000 patients) with 24-month follow-up. Eligible practices will be randomised (1:1) to participate in either the intervention (collaborative quality improvement program) or control (standard care) regimens. Outcomes will be assessed based on randomised allocation, according to intention-to-treat. The primary outcome is the proportion of patients with unplanned CVD hospitalisations at 2 years. Secondary outcomes are proportion of patients with major adverse cardiovascular events, proportion of patients who received prescriptions for guideline-recommended medicines, proportion of patients achieving national risk factor targets and proportion with a chronic disease management plan or review. Differences in the proportion of patients who are hospitalised (as well as binary secondary outcomes) will be analysed using log-binomial regression or robust Poisson regression, if necessary. Discussion Despite extensive research with surrogate outcomes, to the authors’ knowledge, this is the first randomised controlled trial to evaluate the effectiveness of a data-driven collaborative quality improvement intervention on hospitalisations, CVD events and cardiovascular risk amongst patients with CHD in the primary care setting. The use of data linkage for collection of outcomes will enable evaluation of this potentially efficient strategy for improving management of risk and outcomes for people with heart disease. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12619001790134 (dated 20th December 2019).

There is insufficient and inconsistent data regarding the association between diabetes self-management, the process of facilitating the knowledge, skill, and ability necessary for diabetes self-care, and health-related quality of life (HRQOL) in people with diabetes and moderate to severe chronic kidney disease (CKD). In a cross sectional study, participation in diabetes self-management assessed by the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire and HRQOL was examined in 308 patients with diabetes and CKD (stages 3 to 5) recruited from outpatient diabetes and renal clinics of 4 public tertiary hospitals. Associations were examined by Pearson correlation coefficients and hierarchical multiple regression after controlling for potential confounders. An examination of trend across the levels of patient participation in self-management was assessed using a non-parametric test for trend. The median age and interquartile range (IQR) of patients were 68 and 14.8years, respectively with 59% of the population being over 65years old and 69.5% male. The median durations of diabetes and CKD were 18years (IQR-17) and 5years (IQR-8) respectively. General diet, exercise and medication taking were positively associated with at least one HRQOL subscale (all p<0.05) but diabetes specific diet, blood sugar testing and foot checking were not. As levels of participation in self-management activities increased there was a graded increase in mean HRQOL scores across all subscales (p for trend <0.05). In people with diabetes and moderate to severe CKD, participation in diabetes self-management activities, particularly those focused on general diet, exercise and medication taking, was associated with higher HRQOL.

Background Health-care for co-morbid diabetes and chronic kidney disease (CKD) is often sub-optimal. To improve health-care, we explored the perspectives of general practitioners (GPs) and tertiary health-care professionals concerning key factors influencing health-care of diabetes and CKD. Methods A total of 65 health professionals were purposively sampled from Australia’s 2 largest cities to participate in focus groups and semi-structured interviews. Four focus groups were conducted with GPs who referred to 4 tertiary health services in Australia’s 2 largest cities, with 6 focus groups conducted with tertiary health-care professionals from the 4 tertiary health services. An additional 8 semi-structured interviews were performed with specialist physicians who were heads of diabetes and renal units. All discussions were facilitated by the same researcher, with discussions digitally recorded and transcribed verbatim. All qualitative data was thematically analysed independently by 2 researchers. Results Both GPs and tertiary health-care professionals emphasised the importance of primary care and that optimal health-care was an inter-play between patient self-management and primary health-care, with specialist tertiary health-care support. Patient self-management, access to specialty care, coordination of care and a preventive approach were identified as key factors that influence healthcare and require improvement. Both groups suggested that an integrated specialist diabetes-kidney service could improve care. Unit heads emphasised the importance of quality improvement activities. Conclusions GPs and tertiary health-care professionals emphasised the importance of patient self-management and primary care involvement in the health-care of diabetes and CKD. Supporting GPs with an accessible, multidisciplinary diabetes-renal health service underpinned by strong communication pathways, a preventive approach and quality improvement activities, may improve health-care and patient outcomes in co-morbid diabetes and CKD.

IntroductionTechnology-mediated strategies have potential to engage patients in modifying unhealthy behaviour and improving medication adherence to reduce morbidity and mortality from cardiovascular disease (CVD). Furthermore, electronic tools offer a medium by which consumers can more actively navigate personal healthcare information. Understanding how, why and among whom such strategies have an effect can help determine the requirements for implementing them at a scale. This paper aims to detail a process evaluation that will (1) assess implementation fidelity of a multicomponent eHealth intervention; (2) determine its effective features; (3) explore contextual factors influencing and maintaining user engagement; and (4) describe barriers, facilitators, preferences and acceptability of such interventions.Methods and analysisMixed-methods sequential design to derive, examine, triangulate and report data from multiple sources. Quantitative data from 3 sources will help to inform both sampling and content framework for the qualitative data collection: (1) surveys of patients and general practitioners (GPs); (2) software analytics; (3) programme delivery records. Qualitative data from interviews with patients and GPs, focus groups with patients and field notes taken by intervention delivery staff will be thematically analysed. Concurrent interview data collection and analysis will enable a thematic framework to evolve inductively and inform theory building, consistent with a realistic evaluation perspective. Eligible patients are those at moderate-to-high CVD risk who were randomised to the intervention arm of a randomised controlled trial of an eHealth intervention and are contactable at completion of the follow-up period; eligible GPs are the primary healthcare providers of these patients.Ethics and disseminationEthics approval has been received from the University of Sydney Human Research Ethics Committee and the Aboriginal Health and Medical Research Council (AH&MRC) of New South Wales. Results will be disseminated via scientific forums including peer-reviewed publications and national and international conferences.Trial registration numberANZCTR 12613000715774.

Australian evidence-based guidelines recommend regular testing of kidney health in high-risk individuals, and appropriate determination of absolute cardiovascular risk, but implementation appears to be sub-optimal. 2. An estimated one in three Australian adults is at increased risk of developing CKD due to identified risk factors including high blood pressure and diabetes.1 Population surveys have demonstrated that one in ten adults have existing evidence of CKD, but the vast majority of consumers and health professionals are unaware these individuals have this condition.2 Research has shown that early detection and optimal management of CKD can reduce the otherwise potential deterioration in kidney function by up to 50 per cent, with significant benefit in reducing cardiovascular risk and improving quality of life.3 As CKD is primarily asymptomatic, and screening the general population has not been shown to be cost-effective, current preventive guidelines recommend regular testing of kidney health in high-risk individuals.4,5 The usual setting for initial assessment and diagnosis of CKD is in general practice. [...]evidence suggests that CKD is not always adequately detected or appropriately managed in primary care.6,7 Best practice for early detection of CKD is based on the Kidney Health Check4 comprising a blood test for serum creatinine to obtain the estimated glomerular filtration rate (eGFR), urine test for albumin creatinine ratio (ACR), and blood pressure. To maximise response rates, a non-monetary incentive in the form of Royal Australian College of General Practitioners (RACGP) or Australian College of Rural and Remote Medicine (ACRRM) Continuing Professional Development (CPD) credits was offered...

While patient satisfaction with the general practice consultation has been extensively researched, there have been relatively few studies of doctors' perception of patient satisfaction. This study sought to measure how accurately doctors are able to predict patient satisfaction with consultations in general practice. Adult patients consulting about new episodes of illness in general practice completed a consultation satisfaction questionnaire. The scores from the questionnaire were compared with doctors' predictions of patient satisfaction. Nine general practitioners completed the study and returned a total of 167 pairs of questionnaires. On average, the patients gave their doctors higher scores on the general satisfaction and professional care scales than on the depth of relationship and perceived time scales of the questionnaire. On every scale, patients reported higher levels of satisfaction than their doctors predicted they would. There was poor correlation between patient and doctor scores for the perceived time scale, but moderate correlation for the other three scales. Our findings suggest that a doctor's sense that a patient was not satisfied following a consultation may be valid, but that doctors may underestimate their patients' satisfaction.

Introduction: The ageing population together with an increasing prevalence of chronic conditions require a systems wide integrated approach to health care. This includes overcoming barriers between primary and secondary care, physical and mental health, and health and social care in order to provide patient centred care. In Australia, the New South Wales Ministry of Health (NSW MoH) is piloting an innovative Integrated Care Program in Western Sydney (WSICP) focussed on care of those with diabetes, COPD and congestive cardiac failure. Commencing in 2015, WSICP has established multidisciplinary rapid access clinics in two hospitals; initiatives to support General Practices in moving towards a Patient Centred Medical Home model of care as well as establishment of care facilitator roles to coordinate patient care between General Practices and hospitals.Theory/Methods: The NSW MoH is collecting quantitative data on the WSICP that includes hospital admissions and patient and provider engagement. We are undertaking a qualitative evaluation that complements the NSW MoH evaluation to develop an understanding of how the various WSICP strategies are working for all stakeholders. We have conducted the first of two rounds of in-depth semi-structured interviews with 70 participants including patients and carers (20), health care providers from hospitals and the community (40), and management (10). We have analysed the transcribed audio-recorded interviews thematically according to established protocols and will report on themes identified at this early stage of WSICP.Results: We are still analysing the data but expect to be able to report improvements in collaboration and shared care described by health care providers. Patients and their carers have described improved health and health care as well as increased efficacy in self-managing illness and navigating the health system. Rapid clinic access is reported to be preventing hospital admission and reducing waiting times. However, barriers still exist in terms of IT systems and communication, promotion and awareness, and low levels of General Practitioner engagement.Discussions: As WSICP progresses, early successes will enhance engagement with the program. Challenges identified by our evaluation will be addressed. This comprehensive qualitative review in the early phase of the program will not only refine its roll out, but will inform other similar initiatives.Conclusions: The WSICP is facilitating improved patient outcomes and greater health care provider collaboration. Barriers to care integration identified by our evaluation are being addressed.Lessons learned: Our early qualitative evaluation provides opportunities to refine the WSICP and gain understandings of how each element of this comprehensive health services integration pilot is contributing to the intended outcomes.Limitations: Due to the early stage of WSICP implementation, the experiences of stakeholders have varied relative to their length of engagement with the program. Individual program initiatives were also at various stages of operation.Suggestions for future research: The second round of data collection, scheduled for December 2016-February 2017, will provide a comparison against this baseline data. Most interviewees consented to a subsequent interview.