Protocol for cost-effectiveness analysis of a randomised trial of mHealth coaching (Bump2Baby and Me) compared with usual care for healthy gestational weight gain and postnatal outcomes in at-risk women and their offspring in the UK, Australia, Ireland and Spain.

INTRODUCTION: Gestational diabetes mellitus and overweight are associated with an increased likelihood of complications during birth and for the newborn baby. These complications lead to increased immediate and long-term healthcare costs as well as reduced health and well-being in women and infants. This protocol presents the health economic evaluation to investigate the cost-effectiveness of Bump2Baby and Me (B2B&Me), which is a health coaching intervention delivered via smartphone to women at risk of gestational diabetes. METHODS AND ANALYSIS: Using data from the B2B&Me randomised controlled trial, this economic evaluation compares costs and health effects between the intervention and control group as an incremental cost-effectiveness ratio. Direct healthcare costs, costs of pharmaceuticals and intervention costs will be included in the analysis, body weight and quality-adjusted life-years for the mother will serve as the effect outcomes. To investigate the long-term cost-effectiveness of the trial, a Markov model will be employed. Deterministic and probabilistic sensitivity analysis will be employed. ETHICS AND DISSEMINATION: The National Maternity Hospital Human Research and Ethics Committee was the primary approval site (EC18.2020) with approvals from University College Dublin HREC-Sciences (LS-E-20-150-OReilly), Junta de Andalucia CEIM/CEI Provincial de Granada (2087-M1-22), Monash Health HREC (RES-20-0000-892A) and National Health Service Health Research Authority and Health and Care Research Wales (HCRW) (21/WA/0022). The results from the analysis will be disseminated in scientific papers, through conference presentations and through different channels for communication within the project. TRIAL REGISTRATION NUMBER: ACTRN12620001240932.

Low-Intensity mental health Support via a Telehealth Enabled Network for adults with diabetes (LISTEN): protocol for a hybrid type 1 effectiveness implementation trial.

BACKGROUND: Mental health problems are common among people with diabetes. However, evidence-based strategies for the prevention and early intervention of emotional problems in people with diabetes are lacking. Our aim is to assess the real-world effectiveness, cost-effectiveness, and implementation of a Low-Intensity mental health Support via a Telehealth Enabled Network (LISTEN), facilitated by diabetes health professionals (HPs). METHODS: A hybrid type I effectiveness-implementation trial, including a two-arm parallel randomised controlled trial, alongside mixed methods process evaluation. Recruited primarily via the National Diabetes Services Scheme, Australian adults with diabetes (N = 454) will be eligible if they are experiencing elevated diabetes distress. Participants are randomised (1:1 ratio) to LISTEN-a brief, low-intensity mental health support program based on a problem-solving therapy framework and delivered via telehealth (intervention) or usual care (web-based resources about diabetes and emotional health). Data are collected via online assessments at baseline (T0), 8 weeks (T1) and 6 months (T2, primary endpoint) follow-up. The primary outcome is between-group differences in diabetes distress at T2. Secondary outcomes include the immediate (T1) and longer-term (T2) effect of the intervention on psychological distress, general emotional well-being, and coping self-efficacy. A within-trial economic evaluation will be conducted. Implementation outcomes will be assessed using mixed methods, according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Data collection will include qualitative interviews and field notes. DISCUSSION: It is anticipated that LISTEN will reduce diabetes distress among adults with diabetes. The pragmatic trial results will determine whether LISTEN is effective, cost-effective, and should be implemented at scale. Qualitative findings will be used to refine the intervention and implementation strategies as required. TRIAL REGISTRATION: This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN: ACTRN12622000168752) on 1 February, 2022.

Barriers to Uptake of Open-Source Automated Insulin Delivery Systems: Analysis of Socioeconomic Factors and Perceived Challenges of Caregivers of Children and Adolescents With Type 1 Diabetes From the OPEN Survey.

Background: As a treatment option for people living with diabetes, automated insulin delivery (AID) systems are becoming increasingly popular. The #WeAreNotWaiting community plays a crucial role in the provision and distribution of open-source AID technology. However, while a large percentage of children were early adopters of open-source AID, there are regional differences in adoption, which has prompted an investigation into the barriers perceived by caregivers of children with diabetes to creating open-source systems. Methods: This is a retrospective, cross-sectional and multinational study conducted with caregivers of children and adolescents with diabetes, distributed across the online #WeAreNotWaiting online peer-support groups. Participants-specifically caregivers of children not using AID-responded to a web-based questionnaire concerning their perceived barriers to building and maintaining an open-source AID system. Results: 56 caregivers of children with diabetes, who were not using open-source AID at the time of data collection responded to the questionnaire. Respondents indicated that their major perceived barriers to building an open-source AID system were their limited technical skills (50%), a lack of support by medical professionals (39%), and therefore the concern with not being able to maintain an AID system (43%). However, barriers relating to confidence in open-source technologies/unapproved products and fear of digital technology taking control of diabetes were not perceived as significant enough to prevent non-users from initiating the use of an open-source AID system. Conclusions: The results of this study elucidate some of the perceived barriers to uptake of open-source AID experienced by caregivers of children with diabetes. Reducing these barriers may improve the uptake of open-source AID technology for children and adolescents with diabetes. With the continuous development and wider dissemination of educational resources and guidance-for both aspiring users and their healthcare professionals-the adoption of open-source AID systems could be improved.

National analysis of the Modified Monash Model, population distribution and a socio-economic index to inform rural health workforce planning.

AIMS: To describe the population distribution and socio-economic position of residents across all states and territories of Australia, stratified using the 7 Modified Monash Model classifications. The numerical summary, and the methods described, can be applied by a variety of end users including workforce planners, researchers, policy-makers and funding bodies for guiding future investment under different scenarios, and aid in evaluating geographically focused programs. CONTEXT: The Commonwealth Department of Health is transitioning to the Modified Monash Model to objectively describe geographical access. This change applies to the Rural Health Multidisciplinary Training Program, one of the Australian Government's key policies to address the maldistribution of the rural health workforce. Unlike the previously applied Australian Statistical Geography Standard-Remoteness Areas, a summary of the population in each Modified Monash Model classification is not available, nor is a socio-economic overview of the communities within these areas. APPROACH: Spatial analysis of Australian Bureau of Statistics data (Modified Monash Model, population data and the Index of Relative Socio-economic Advantage and Disadvantage collected or derived from the 2016 census) at the Statistical Area 1-the smallest unit for the release of census data. CONCLUSION: Linking the Modified Monash Model, a socio-economic index and granular population data at the national level highlights the disadvantage of many residents in small rural towns (Modified Monash 5). The Modified Monash Model does not exhibit a continuum of the largest population residing in the most accessible classification and the smallest population residing in the least accessible classification that is seen in the Australian Statistical Geography Standard-Remoteness Areas. Coupled with policy relevance, the advantage of using the Modified Monash Model as the basis for analysis is that it highlights areas that have both a critical mass of residents and differing levels of socio-economic advantage and disadvantage. This will help end users to target funding to those regions where there is potential to improve access to services for the greatest number of rural residents.

Assessment of the Depression, Anxiety, and Stress Scale (DASS-21) in untreated obstructive sleep apnea (OSA).

The assessment of depression in obstructive sleep apnea (OSA) is confounded by symptom overlap. The Depression, Anxiety, and Stress Scale-short form (DASS-21) is a commonly used measure of negative affect, but it not known whether the DASS-21 is suitable for use in an OSA sample. This study compared the fit of Lovibond and Lovibond's (1995) correlated 3-factor structure of the DASS-21 and measurement invariance between a non-OSA and an OSA sample using confirmatory factor analysis. As measurement invariance was not found, to determine the source of non-invariance differential item functioning (DIF) was examined using dMACS. The correlated 3-factor structure (with correlated errors) of the DASS-21 was a better fit in the non-OSA sample. dMACS indicated that there was a degree of DIF for each of the subscales, especially for the Anxiety subscale, in which 2 symptoms (that are also physiological symptoms of OSA) produced lower severity scores in the OSA sample compared with the non-OSA sample. However, the degree of DIF for each of the subscales is not sufficient to cause concern when using the DASS-21; therefore, the total DASS-21 is suitable for use in an OSA sample. Interestingly, the impact of symptom overlap in anxiety symptoms may be reducing anxiety scores because of DIF, which contrasts with the proposed effect of symptom overlap in depression, where it leads to the inflation of depression scores in OSA. This deserves greater consideration in relation to OSA and other clinical disorders or chronic illness conditions with different patterns of overlapping symptoms. (PsycINFO Database Record

Specific psychological variables predict quality of diet in women of lower, but not higher, educational attainment.

Our previous work found that perceived control over life was a significant predictor of the quality of diet of women of lower educational attainment. In this paper, we explore the influence on quality of diet of a range of psychological and social factors identified during focus group discussions, and specify the way this differs in women of lower and higher educational attainment. We assessed educational attainment, quality of diet, and psycho-social factors in 378 women attending Sure Start Children's Centres and baby clinics in Southampton, UK. Multiple-group path analysis showed that in women of lower educational attainment, the effect of general self-efficacy on quality of diet was mediated through perceptions of control and through food involvement, but that there were also direct effects of social support for healthy eating and having positive outcome expectancies. There was no effect of self-efficacy, perceived control or outcome expectancies on the quality of diet of women of higher educational attainment, though having more social support and food involvement were associated with improved quality of diet in these women. Our analysis confirms our hypothesis that control-related factors are more important in determining dietary quality in women of lower educational attainment than in women of higher educational attainment.