Remotely delivered physiotherapy is as effective as face-to-face physiotherapy for musculoskeletal conditions (REFORM): a randomised trial.

QUESTION: Is remotely delivered physiotherapy as good or better than face-to-face physiotherapy for the management of musculoskeletal conditions? DESIGN: Randomised controlled, non-inferiority trial with concealed allocation, blinded assessors and intention-to-treat analysis. PARTICIPANTS: A total of 210 adult participants with a musculoskeletal condition who presented for outpatient physiotherapy at five public hospitals in Sydney. INTERVENTION: One group received a remotely delivered physiotherapy program for 6 weeks that consisted of one face-to-face physiotherapy session in conjunction with weekly text messages, phone calls at 2 and 4 weeks, and an individualised home exercise program delivered through an app. The other group received usual face-to-face physiotherapy care in an outpatient setting. OUTCOME MEASURES: The primary outcome was the Patient Specific Functional Scale at 6 weeks with a pre-specified non-inferiority margin of -15 out of 100 points. Secondary outcomes included: the Patient Specific Functional Scale at 26 weeks; kinesiophobia, pain, function/disability, global impression of change and quality of life at 6 and 26 weeks; and satisfaction with service delivery at 6 weeks. RESULTS: The mean between-group difference (95% CI) for the Patient Specific Functional Scale at 6 weeks was 2.7 out of 100 points (-3.5 to 8.8), where a positive score favoured remotely delivered physiotherapy. The lower end of the 95% CI was greater than the non-inferiority margin. Whilst non-inferiority margins were not set for the secondary outcomes, the 95% CI of the mean between-group difference ruled out clinically meaningful differences. CONCLUSION: Remotely delivered physiotherapy with support via phone, text and an app is as good as face-to-face physiotherapy for the management of musculoskeletal conditions. TRIAL REGISTRATION: ACTRN12619000065190.

Differences in weight status among Australian children and adolescents from priority populations: a longitudinal study.

BACKGROUND AND SIGNIFICANCE: Australia has a high level of cultural and linguistic diversity, including Aboriginal and Torres Strait Islander peoples. Children from specific cultural and ethnic groups may be at greater risk of overweight and obesity and may bear the additional risk of socioeconomic disadvantage. Our aim was to identify differences in body-mass index z-score (zBMI) by: (1) Cultural and ethnic groups and; (2) Socioeconomic position (SEP), during childhood and adolescence. SUBJECTS/METHODS: We used data from the Longitudinal Study of Australian children (n = 9417) aged 2-19 years with 50870 longitudinal measurements of zBMI. Children were classified into 9 cultural and ethnic groups, based on parent and child's country of birth and language spoken at home. These were: (1) English-speaking countries; (2) Middle East & North Africa; (3) East & South-East Asia; (4) South & Central Asia; (5) Europe; (6) Sub-Saharan Africa; (7) Americas; (8) Oceania. A further group (9) was defined as Aboriginal and Torres Strait Islander from self-reported demographic information. Longitudinal cohort analyses in which exposures were cultural and ethnic group and family socioeconomic position, and the outcome was zBMI estimated using multilevel mixed linear regression models. We stratified our analyses over three periods of child development: early childhood (2-5 years); middle childhood (6-11 years); and adolescence (12-19 years). RESULTS: Across all three periods of child development, children from the Middle East and North Africa, the Americas and Oceania were associated with higher zBMI and children from the two Asian groups were associated with lower zBMI, when compared to the referent group (English). zBMI was socioeconomically patterned, with increasingly higher zBMI associated with more socioeconomic disadvantage. CONCLUSIONS: Our findings identified key population groups at higher risk of overweight and obesity in childhood and adolescence. Prevention efforts should prioritize these groups to avoid exacerbating inequalities in healthy weight in childhood.

Longitudinal associations between socioeconomic position and overall health of children with chronic kidney disease and their carers.

BACKGROUND: Disadvantaged socioeconomic position (SEP) is an important predictor of poor health in children with chronic kidney disease (CKD). The time course over which SEP influences the health of children with CKD and their carers is unknown. METHODS: This prospective longitudinal study included 377 children, aged 6-18 years with CKD (stages I-V, dialysis, and transplant), and their primary carers. Mixed effects ordinal regression was performed to assess the association between SEP and carer-rated child health and carer self-rated health over a 4-year follow-up. RESULTS: Adjusted for CKD stage, higher family household income (adjusted odds ratio (OR) (95% CI) 3.3, 1.8-6.0), employed status of primary carers (1.7, 0.9-3.0), higher carer-perceived financial status (2.6, 1.4-4.8), and carer home ownership (2.2, 1.2-4.0) were associated with better carer-rated child health. Household income also had a differential effect on the carer's self-rated health over time (p = 0.005). The predicted probabilities for carers' overall health being 'very good' among lower income groups at 0, 2, and 4 years were 0.43 (0.28-0.60), 0.34 (0.20-0.51), and 0.25 (0.12-0.44), respectively, and 0.81 (0.69-0.88), 0.84 (0.74-0.91), and 0.88 (0.76-0.94) for carers within the higher income group. CONCLUSIONS: Carers and their children with CKD in higher SEP report better overall child and carer health compared with those in lower SEP. Carers of children with CKD in low-income households had poorer self-rated health compared with carers in higher-income households at baseline, and this worsened over time. These cumulative effects may contribute to health inequities between higher and lower SEP groups over time. Graphical abstract A higher resolution version of the Graphical abstract is available as Supplementary information.

Integrated Text Messaging (ITM) for people attending cardiac and pulmonary rehabilitation: A multicentre randomised controlled trial.

BACKGROUND: People living with cardiac and respiratory disease require improved post-hospital support that is readily available and efficient. OBJECTIVES: To 1) test the effectiveness of an automated, semi-personalised text message support program on clinical and lifestyle outcomes amongst people attending cardiac and pulmonary rehabilitation. Also, 2) to evaluate the program's acceptability and utility using patient-reported outcome and experience measures. METHODS: Multicentre randomised controlled trial (3:1, intervention:control) amongst cardiac and pulmonary rehabilitation attendees. Control received usual care (no message program). Intervention also received a 6-month text message lifestyle and support program. Primary outcome was 6-minute walk distance (6MWD). Secondary outcomes included clinical measures, lifestyle, patient-reported outcome and experience measures, medication adherence and rehabilitation attendance. RESULTS: A total of 316 participants were recruited. They had a mean age of 66.7 (SD 10.1) years. Sixty percent were male (190/316) and 156 were cardiac rehabilitation participants. The cohort's mean baseline 6MWD was higher in the intervention than the control group. At 6 months, 6MWD improved in both groups; it was significantly greater amongst intervention than control participants (unadjusted mean difference of 43.4 m, 95 % CI 4.3 to 82.4; P = 0.0296). After adjustment for baseline values, there was no significant difference between intervention and control groups for 6MWD (adjusted mean difference 2.2 m, -21.2 to 25.6; P = 0·85), medication adherence, or cardiovascular risk factors. At 6-month follow-up, intervention participants reported significantly lower depression scores (adjusted mean difference -1.3, 95 % CI -2.2 to -0.3; P = 0.0124) and CAT scores (adjusted mean difference -3.9, 95 % CI -6.6 to -1.3; P = 0.0038), and significantly lower anxiety (adjusted mean difference -1.1, 95 %CI -2.1 to 0; P = 0.0456). Most participants (86 %) read most of their messages and strongly/agreed that the intervention was easy to understand (99 %) and useful (86 %). CONCLUSIONS: An educational and supportive text message program for cardiac and pulmonary rehabilitation attendees improved anxiety and depression plus program attendance. The program was acceptable to, and useful for, participants and would be suitable for implementation alongside rehabilitation programs. TRIAL REGISTRATION NUMBER: ACTRN12616001167459.

T-cell lymphoma involving the rectum of a dog.

A mediastinal mass was diagnosed in a 7-year-4-month-old neutered female mixed breed dog following a 3-week history of lethargy, hyporexia and pyrexia. Bi-cavitary imaging, needle aspirate cytology and flow cytometry confirmed WHO clinical stage IVb, intermediate to large T-cell lymphoma involving the mediastinum, liver and spleen. The dog initially responded to a multidrug chemotherapy protocol but clinical deterioration occurred 3 months later. The dog presented with anorexia, vomiting and diarrhoea, associated with marked faecal tenesmus and haematochezia, initially believed by the primary care practitioner to be related to chemotherapy toxicity. However, rectal examination revealed multiple sessile and pedunculated masses. Further diagnostic imaging, cytology and flow cytometry confirmed progressive disease, including T-cell lymphoma of the rectum. Histology and immunohistochemistry confirmed an infiltrate of intermediate-sized CD3-positive neoplastic cells that expanded the rectal mucosa. Rectal lymphoma is uncommon in dogs and previous cases have been B cell in origin. In this report we describe the clinical presentation and macro- and microscopic findings of a case of canine T-cell lymphoma involving the rectum.

Psychometric Evaluation of the PedsQL GCS and CHU9D in Australian Children and Adolescents with Common Chronic Health Conditions.

BACKGROUND: Generic instruments such as the Pediatric Quality of Life Inventory™ v4.0 Generic Core Scales (PedsQL GCS) and Child Health Utility 9D (CHU9D) are widely used to assess health-related quality of life (HRQOL) of the general childhood population, but there is a paucity of information about their psychometric properties in children with specific health conditions. This study assessed psychometric properties, including acceptability, reliability, validity, and responsiveness, of the PedsQL GCS and the CHU9D in children and adolescents with a range of common chronic health problems. METHODS: We used data from the Longitudinal Study of Australian Children (LSAC), for children aged 10-17 years with at least one of the following six parent-reported health conditions: asthma, anxiety/depression, attention deficit hyperactivity disorder (ADHD), autism/Asperger's, epilepsy, and type 1 diabetes mellitus. The LSAC used parent proxy-reported PedsQL GCS and child self-reported CHU9D assessments. The performance of each instrument (PedsQL GCS and CHU9D) for each psychometric property (acceptability, reliability, validity, and responsiveness) was assessed against established criteria. RESULTS: The study sample included 7201 children and adolescents (mean age = 14 years; range 10.1-17.9 years; 49% female) with 15,568 longitudinal observations available for analyses. Across the six health conditions, acceptability of the PedsQL GCS was high, while acceptability for the CHU9D was mixed. Both the PedsQL GCS and CHU9D showed strong internal consistency (Cronbach's alpha range: PedsQL GCS = 0.70-0.95, CHU9D = 0.76-0.84; item-total correlations range: PedsQL GCS = 0.35-0.84, CHU9D = 0.32-0.70). However, convergent validity for both the PedsQL GCS and CHU9D was generally weak (Spearman's correlations ≤ 0.3). Known group validity was strong for the PedsQL GCS (HRQOL differences were detected for children with and without asthma, anxiety/depression, ADHD, autism/Asperger's, and epilepsy). CHU9D was only able to discriminate between children with and without anxiety/depression, ADHD, and autism/Asperger's. The responsiveness of both the PedsQL GCS and CHU9D was variable across the six conditions, and most of the estimated effect sizes were relatively small (< 0.5). CONCLUSION: This study expands the evidence base of psychometric performance of the PedsQL GCS and CHU9D and can aid in appropriate HRQOL instrument selection for the required context by researchers and clinicians.

Modelled Distributional Cost-Effectiveness Analysis of Childhood Obesity Interventions: A Demonstration.

OBJECTIVE: To demonstrate how distributional cost-effectiveness analyses of childhood obesity interventions could be conducted and presented for decision makers. METHODS: We conducted modelled distributional cost-effectiveness analyses of three obesity interventions in children: an infant sleep intervention (POI-Sleep), a combined infant sleep, food, activity and breastfeeding intervention (POI-Combo) and a clinician-led treatment for primary school-aged children with overweight and obesity (High Five for Kids). For each intervention, costs and socioeconomic position (SEP)-specific effect sizes were applied to an Australian child cohort (n = 4898). Using a purpose-built microsimulation model we simulated SEP-specific body mass index (BMI) trajectories, healthcare costs and quality-adjusted life years (QALYs) from age 4 to 17 years for control and intervention cohorts. We examined the distribution of each health outcome across SEP and determined the net health benefit and equity impact accounting for opportunity costs and uncertainty due to individual-level heterogeneity. Finally, we conducted scenario analyses to test the effect of assumptions about health system marginal productivity, the distribution of opportunity costs and SEP-specific effect sizes. The results of the primary analyses, uncertainty analyses and scenario analyses were presented on an efficiency-equity impact plane. RESULTS: Accounting for uncertainty, POI-Sleep and High Five for Kids were found to be 'win-win' interventions, with a 67% and 100% probability, respectively, of generating a net health benefit and positive equity impact compared with control. POI-Combo was found to be a 'lose-lose' intervention, with a 91% probability of producing a net health loss and a negative equity impact compared with control. Scenario analyses indicated that SEP-specific effect sizes were highly influential on equity impact estimates for POI-Combo and High Five for Kids, while health system marginal productivity and opportunity cost distribution assumptions primarily influenced the net health benefit and equity impact of POI-Combo. CONCLUSIONS: These analyses demonstrated that distributional cost-effectiveness analyses using a fit-for-purpose model are appropriate for differentiating and communicating the efficiency and equity impacts of childhood obesity interventions.

Economic evaluation of a mobile phone text-message intervention for Australian adults with type 2 diabetes.

Background: The rising prevalence of type 2 diabetes in Australia is a public health concern, contributing to significant disease burden and economic costs. Text-message programs have been shown to improve health outcomes for people with type 2 diabetes, however they remain underutilized, and no evidence exists on their cost-effectiveness or costs of scale up to a population level in Australia. This study aimed to determine the cost-effectiveness and cost-utility of a 6-month text-message intervention (DTEXT) to improve glycated hemoglobin (HbA1c) and self-management behaviors for Australian adults with type 2 diabetes. Methods: A within-trial economic evaluation was conducted on the DTEXT randomized controlled trial. Incremental cost-effectiveness ratios (ICERs) were determined per 11 mmol/mol (1%) reduced HbA1c and per quality adjusted life year (QALY) gained, compared to usual care. Cost-effectiveness acceptability curves (CEAC) determined the probability of the intervention being cost-effective over a range of willingness to pay thresholds. A scenario analysis was conducted to determine how cost-effectiveness was impacted by using current implementation costs. Results: The DTEXT intervention cost AU$36 (INT$24) per participant, with an ICER of AU$311 (INT$211) per 11 mmol/mol (1%) reduced HbA1c. Based on HbA1c outcomes, DTEXT had a 33% probability of being effective and cost-saving. Based on the QALY outcomes, the intervention had only a 24% probability of being cost-effective. Scenario analysis indicated costs per participant of AU$13 (INT$9) to deliver the intervention, with a reduced incremental cost effectiveness ratio of AU$151 (INT$103) per 11 mmol/mol (1%) reduced HbA1c and a 38% probability of being effective and cost-saving. Conclusions: DTEXT was low cost and potentially scalable, but only had a low to moderate probability of being effective and cost saving. Further research should determine more targeted approaches that may improve cost-effectiveness. Trial Registration: ACTRN12617000416392.

Reliability, acceptability, validity and responsiveness of the CHU9D and PedsQL in the measurement of quality of life in children and adolescents with overweight and obesity.

BACKGROUND: The Paediatric Quality of life Inventory (PedsQLTM) Generic Core Scales and the Child Health Utilities 9 Dimensions (CHU9D) are two paediatric health-related quality of life (HRQoL) measures commonly used in overweight and obesity research. However, no studies have comprehensively established the psychometric properties of these instruments in the context of paediatric overweight and obesity. The aim of this study was to assess the reliability, acceptability, validity and responsiveness of the PedsQL and the CHU9D in the measurement of HRQoL among children and adolescents living with overweight and obesity. SUBJECTS/METHODS: Subjects were 6544 child participants of the Longitudinal Study of Australian Children, with up to 3 repeated measures of PedsQL and CHU9D and aged between 10 and 17 years. Weight and height were measured objectively by trained operators, and weight status determined using World Health Organisation growth standards. We examined reliability, acceptability, known group and convergent validity and responsiveness, using recognised methods. RESULTS: Both PedsQL and CHU9D demonstrated good internal consistency reliability, and high acceptability. Neither instrument showed strong convergent validity, but PedsQL appears to be superior to the CHU9D in known groups validity and responsiveness. Compared with healthy weight, mean (95%CI) differences in PedsQL scores for children with obesity were: boys -5.6 (-6.2, -4.4); girls -6.7 (-8.1, -5.4) and differences in CHU9D utility were: boys -0.02 (-0.034, -0.006); girls -0.035 (-0.054, -0.015). Differences in scores for overweight compared with healthy weight were: PedsQL boys -2.2 (-3.0, -1.4) and girls -1.3 (-2.0, -0.6) and CHU9D boys: no significant difference; girls -0.014 (-0.026, -0.003). CONCLUSION: PedsQL and CHU9D overall demonstrated good psychometric properties, supporting their use in measuring HRQoL in paediatric overweight and obesity. CHU9D had poorer responsiveness and did not discriminate between overweight and healthy weight in boys, which may limit its use in economic evaluation.

Twelve-month effectiveness of telephone and SMS support to mothers with children aged 2 years in reducing children's BMI: a randomized controlled trial.

BACKGROUND/OBJECTIVES: Few quality intervention studies have assessed whether a combined telephone and short message service (SMS) intervention to mothers is effective in reducing BMI and obesity risk behaviors of children at 3 years of age. This study aimed to assess effectiveness of telephone and SMS support in reducing children's body mass index (BMI) and obesity risk behaviors. SUBJECTS/METHODS: A randomized controlled trial (RCT) with 662 women of 2-year-old children (with the proportion of overweight and obesity being similar to the general population) was conducted in Sydney, Australia, March 2019-October 2020. The mothers in the intervention group received three telephone support sessions plus SMS messages and mailed-intervention-booklets over a 12 months period i.e., 24-26, 28-30, and 32-34 months of the child's age. Mothers in the control group received usual care and two mailed booklets on information not related to the intervention. The primary outcome was child's BMI at 3 years of age. Secondary outcomes were children's dietary and activity behaviors. All outcome measures were based on mothers' self-report using standardized tools due to COVID-19 pandemic restrictions. RESULTS: 537 (81%) mothers completed the post-intervention assessment at 3 years with only 470 (71%) children having weight and height measures. Multiple imputation analysis showed no statistically significant difference in mean BMI between the groups. Children in the intervention group were more likely not to eat in front of the TV [AOR 1.79 (95% CI 1.17-2.73), P = 0.008], more likely to meet the dietary recommendations [AOR 1.73 (95% CI 0.99-3.02), P = 0.054] and meet the activity recommendations [AOR 1.72 (95% CI 1.11-2.67), P = 0.015] than those in the control group respectively. Among those with an annual household income (

Effectiveness and co-benefits of a telephone-based intervention in reducing obesity risk of children aged 2-4 years: findings from a pragmatic randomised controlled trial during the COVID-19 pandemic in Australia.

BACKGROUND: Evidence of effective early childhood obesity prevention is scarce and mainly derived from face-to-face interventions. However, the COVID-19 pandemic drastically reduced face-to-face health programmes globally. This study assessed effectiveness of a telephone-based intervention in reducing obesity risk of young children. METHODS: We adapted a study protocol (developed before the pandemic) and conducted a pragmatic randomised controlled trial of 662 women with children aged 2 years (mean age 24·06 months [SD 0·69]) during March, 2019, and October, 2021, extending the original planned intervention of 12 months to 24 months. The adapted intervention comprised five telephone-based support sessions plus text messages over a 24-month period (at child ages 24-26 months, 28-30 months, 32-34 months, 36-38 months, and 42-44 months). The intervention group (n=331) received staged telephone plus SMS support regarding healthy eating, physical activity, and information about COVID-19. The control group (n=331) received four staged mail-outs on information not related to the obesity prevention intervention, such as toilet training, language development, and sibling relationships, as a retention strategy. The intervention effects on BMI (primary outcome) and eating habits (secondary outcome), and perceived co-benefits, were evaluated using surveys and qualitative telephone interviews at 12 months and 24 months after baseline (age 2 years). The trial is registered with the Australian Clinical Trial Registry, ACTRN12618001571268. FINDINGS: Of 662 mothers, 537 (81%) completed the follow-up assessments at 3 years, and 491 (74%) completed the follow-up assessment at 4 years. Multiple imputation analysis showed no significant difference in mean BMI between the groups. Among low-income families (ie, annual household income

Potential cost-effectiveness of e-health interventions for treating overweight and obesity in Australian adolescents.

BACKGROUND: E-health, defined as the use of information and communication technologies to improve healthcare delivery and health outcomes, has been promoted as a cost-effective strategy to treat adolescent overweight and obesity. However, evidence supporting this claim is lacking. OBJECTIVES: Assess the potential cost-effectiveness of a hypothetical e-health intervention for adolescents with overweight and obesity. METHODS: The costs and effect size (BMI reduction) of the hypothetical intervention were sourced from recent systematic reviews. Using a micro-simulation model with a lifetime time horizon, we conducted a modelled cost-utility analysis of the intervention compared to a 'do-nothing' approach. To explore uncertainty, we conducted bootstrapping on individual-level costs and quality-adjusted life years (QALYs) and performed multiple one-way sensitivity analyses. RESULTS: The incremental cost-effectiveness ratio (ICER) for the e-health intervention was dominant (cheaper and more effective), with a 96% probability of being cost-effective at a willingness-to-pay (WTP) of $50 000/QALY. The ICER remained dominant in all sensitivity analyses except when using the lower bounds of the hypothetical intervention effect size, which reduced the probability of cost-effectiveness at a WTP of $50 000/QALY to 51%. CONCLUSION: E-health interventions for treatment of adolescent overweight and obesity demonstrate very good cost-effectiveness potential and should be considered by healthcare decision makers. However, further research on the efficacy of such interventions is warranted to strengthen the case for investment.

Is the cost-effectiveness of an early-childhood sleep intervention to prevent obesity affected by socioeconomic position?

OBJECTIVE: This study aimed to determine whether the cost-effectiveness of an infant sleep intervention from the Prevention of Overweight in Infancy (POI) trial was influenced by socioeconomic position (SEP). METHODS: An SEP-specific economic evaluation of the sleep intervention was conducted. SEP-specific intervention costs and effects at age 5 years, derived from the trial data, were applied to a representative cohort of 4,898 4- to 5-year-old Australian children. Quality-adjusted life years and health care costs were simulated until age 17 years using a purpose-built SEP-specific model. Incremental cost-effectiveness ratios and acceptability curves were derived for each SEP group. RESULTS: The incremental cost-effectiveness ratios, in Australian dollars per quality-adjusted life year gained, were smaller in the low- ($23,010) and mid-SEP ($18,206) groups compared with the high-SEP group ($31,981). The probability that the intervention was cost-effective was very high in the low- and mid-SEP groups (92%-100%) and moderately high in the high-SEP group (79%). CONCLUSIONS: An infant sleep intervention is more cost-effective in low- and mid-SEP groups compared with high-SEP groups. Targeting this intervention to low-SEP groups would not require trade-offs between efficiency and equity.

Longitudinal assessment of the health-related quality of life of children and adolescents with chronic kidney disease.

In this multi-center longitudinal cohort study conducted in Australia and New Zealand, we assessed the trajectories of health-related quality of life (HRQoL) in children with chronic kidney disease (CKD) over time. A total of 377 children (aged 6-18 years) with CKD stages 1-5 (pre-dialysis), dialysis, or transplant, were followed biennially for four years. Multi Attribute Utility (MAU) scores of HRQoL were measured at baseline and at two and four years using the McMaster Health Utilities Index Mark 3 tool, a generic multi-attribute, preference-based system. A multivariable linear mixed model was used to assess the trajectories of HRQoL over time in 199 children with CKD stage 1-5, 43 children receiving dialysis and 135 kidney transplant recipients. An interaction between CKD stage at baseline and follow-up time indicated that the slopes of the HRQoL scores differed between children by CKD stage at inception. Over half of the cohort on dialysis at baseline had received a kidney transplant by the end of year four and the MAU scores of these children increased by a meaningful amount averaging 0.05 (95% confidence interval 0.01 to 0.09) per year in comparison to those who were transplant recipients at baseline. The mean difference between baseline and year two MAU scores was 0.09 (95% confidence interval -0.05, 0.23), (Cohen's d effect size 0.31). Thus, improvement in HRQoL over time of children on dialysis at baseline was likely to have been driven by their transition from dialysis to transplantation. Additionally, children with CKD stage 1-5 and transplant recipients at baseline had no changes in their disease stage or treatment modality and experienced stable HRQoL over time.

Economic evaluation of digitally enabled aged and neurological rehabilitation care in the Activity and MObility UsiNg Technology (AMOUNT) trial.

OBJECTIVE: To investigate the trial-based cost-effectiveness of the addition of a tailored digitally enabled exercise intervention to usual care shown to be clinically effective in improving mobility in the Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial compared to usual care alone. DESIGN: Economic evaluation alongside a pragmatic randomized controlled trial. PARTICIPANTS: 300 people receiving inpatient aged and neurological rehabilitation were randomized to the intervention (n = 149) or usual care control group (n = 151). MAIN MEASURES: Incremental cost effectiveness ratios were calculated for the additional costs per additional person demonstrating a meaningful improvement in mobility (3-point in Short Physical Performance Battery) and quality-adjusted life years gained at 6 months (primary analysis). The joint probability distribution of costs and outcomes was examined using bootstrapping. RESULTS: The mean cost saving for the intervention group at 6 months was AU$2286 (95% Bootstrapped cost CI: -$11,190 to $6410) per participant; 68% and 67% of bootstraps showed the intervention to be dominant (i.e. more effective and cost saving) for mobility and quality-adjusted life years, respectively. The probability of the intervention being cost-effective considering a willingness to pay threshold of AU$50,000 per additional person with a meaningful improvement in mobility or quality-adjusted life year gained was 93% and 77%, respectively. CONCLUSIONS: The AMOUNT intervention had a high probability of being cost-effective if decision makers are willing to pay AU$50,000 per meaningful improvement in mobility or per quality-adjusted life year gained, and a moderate probability of being cost-saving and effective considering both outcomes at 6 months post randomization.

Estimation and feasibility of correction modelling for mother-reported child height and weight at 2 years using data from the Australian CHAT trial.

Correction modelling using reported BMI values has been employed in adolescent and adult populations to improve the accuracy of self-reporting. This study aimed to evaluate the feasibility of establishing correction modelling for mother-reported child height and weight at 2 years using data from an Australian trial in 2019. Correction modelling for BMI was conducted using mother-reported and objectively measured height and weight of 2-year-olds. Mother-reported height, weight and BMI values of 2-year-old children were adjusted based on objectively measured anthropometric data using linear regression models. 'Direct' and 'indirect' corrections were applied to the correction of BMI values. We defined the direct collection as using corrected BMI values that were predicted directly by the model and indirect correction as using corrected weight and height values to calculate corrected BMI values. Corrected BMI values via the indirect correction showed higher sensitivity or similar specificity in predicting overweight status, compared to the direct correction, and also showed higher agreement with measured values compared to the mother-reported measures. Corrected self-reported measures via an indirect correction had a better accuracy and agreement with the objectively measured data in the BMI values and classification of overweight, compared to the mother-reported values.

Economic evaluation of the Communicating Healthy Beginnings Advice by Telephone trial for early childhood obesity prevention.

OBJECTIVE: This study aimed to conduct an economic evaluation of the Communicating Healthy Beginnings Advice by Telephone (CHAT) trial to prevent childhood obesity. METHODS: Cost-effectiveness analyses were conducted for the telephone and short message service (SMS) delivery of Healthy Beginnings advice, compared with usual care, which included child health services unrelated to Healthy Beginnings. Costs were valued in 2018 Australian dollars, and costs and outcomes were discounted at 5% per year. The costs of upscaling both delivery modes to all yearly births in New South Wales, Australia, were estimated and compared with the original Healthy Beginnings home-visiting intervention. RESULTS: At child age 2 years, the SMS delivery was more cost-effective ($5154 per unit BMI and $979 per 0.1 BMI z score units avoided) than the telephone delivery ($10,665 per unit BMI and $2017 per 0.1 BMI z score units avoided). The costs of upscaling the SMS ($7.64 million) and the telephone delivery modes ($37.65 million) were lower than the home-visiting intervention ($108.45 million). CONCLUSIONS: SMS delivery of Healthy Beginnings advice was more cost-effective than telephone delivery but less cost-effective than the original home-visiting approach ($4230 per unit BMI avoided, as calculated in an earlier study). Both the SMS and telephone interventions were more affordable than the home-visiting approach.

Compassion Focused Group Therapy for People With a Diagnosis of Bipolar Affective Disorder: A Feasibility Study.

Background: Compassion focused therapy (CFT) is an evolutionary informed, biopsychosocial approach to mental health problems and therapy. It suggests that evolved motives (e.g., for caring, cooperating, competing) are major sources for the organisation of psychophysiological processes which underpin mental health problems. Hence, evolved motives can be targets for psychotherapy. People with certain types of depression are psychophysiologically orientated towards social competition and concerned with social status and social rank. These can give rise to down rank-focused forms of social comparison, sense of inferiority, worthlessness, lowered confidence, submissive behaviour, shame proneness and self-criticism. People with bipolar disorders also experience elevated aspects of competitiveness and up rank status evaluation. These shift processing to a sense of superiority, elevated confidence, energised behaviour, positive affect and social dominance. This is the first study to explore the feasibility of a 12 module CFT group, tailored to helping people with a diagnosis of bipolar disorder understand the impact of evolved competitive, status-regulating motivation on their mental states and the value of cultivating caring and compassion motives and their psychophysiological regulators. Methods: Six participants with a history of bipolar disorder took part in a CFT group consisting of 12 modules (over 25 sessions) as co-collaborators to explore their personal experiences of CFT and potential processes of change. Assessment of change was measured via self-report, heart rate variability (HRV) and focus groups over three time points. Results: Although changes in self-report scales between participants and across time were uneven, four of the six participants consistently showed improvements across the majority of self-report measures. Heart rate variability measures revealed significant improvement over the course of the therapy. Qualitative data from three focus groups revealed participants found CFT gave them helpful insight into: how evolution has given rise to a number of difficult problems for emotion regulation (called tricky brain) which is not one's fault; an evolutionary understanding of the nature of bipolar disorders; development of a compassionate mind and practices of compassion focused visualisations, styles of thinking and behaviours; addressing issues of self-criticism; and building a sense of a compassionate identity as a means of coping with life difficulties. These impacted their emotional regulation and social relationships. Conclusion: Although small, the study provides evidence of feasibility, acceptability and engagement with CFT. Focus group analysis revealed that participants were able to switch from competitive focused to compassion focused processing with consequent improvements in mental states and social behaviour. Participants indicated a journey over time from 'intellectually' understanding the process of building a compassionate mind to experiencing a more embodied sense of compassion that had significant impacts on their orientation to (and working with) the psychophysiological processes of bipolar disorder.

Protocol for a process evaluation: face-to-face physiotherapy compared with a supported home exercise programme for the management of musculoskeletal conditions: the REFORM trial.

INTRODUCTION: The REFORM (REhabilitation FOR Musculoskeletal conditions) trial is a non-inferiority randomised controlled trial (n=210) designed to determine whether a supported home exercise programme is as good or better than a course of face-to-face physiotherapy for the management of some musculoskeletal conditions. The trial is currently being conducted across Sydney government hospitals in Australia. This process evaluation will run alongside the REFORM trial. It combines qualitative and quantitative data to help explain the trial results and determine the feasibility of rolling out supported home exercise programmes in settings similar to the REFORM trial. METHODS AND ANALYSIS: Two theoretical frameworks underpin our process evaluation methodology: the Realist framework (context, mechanism, outcomes) considers the causal assumptions as to why a supported home exercise programme may be as good or better than face-to-face physiotherapy in terms of the context, mechanisms and outcomes of the trial. The RE-AIM framework describes the Reach, Effectiveness, Adoption, Implementation and Maintenance of the intervention. These two frameworks will be broadly used to guide this process evaluation using a mixed-methods approach. For example, qualitative data will be derived from interviews with patients, healthcare professionals and stakeholders, and quantitative data will be collected to determine the cost and feasibility of providing supported home exercise programmes. These data will be analysed iteratively before the analysis of the trial results and will be triangulated with the results of the primary and secondary outcomes. ETHICS AND DISSEMINATION: This trial will be conducted in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2018) and the Note for Good Clinical Practice (CPMP/ICH-135/95). Ethical approval was obtained on 17 March 2017 from the Northern Sydney Local Health District Human Research Ethics Committee (trial number: HREC/16HAWKE/431-RESP/16/287) with an amendment for the process evaluation approved on 4 February 2020. The results of the process evaluation will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBER: ACTRN12619000065190.

Demographic Predictors of Mothers' Willingness to Vaccinate Young Children Against COVID-19, Get Tested and Isolate: A Cross-Sectional Survey Before and During the Greater Sydney Lockdown 2021, Australia.

Background and Objectives: Having a COVID-19 vaccination, getting tested, and self-isolating if symptomatic are some of the most important mitigation strategies for preventing the spread of COVID-19. This study aimed to investigate whether demographic factors are associated with mothers' willingness to vaccinate their 4-year-old children against COVID-19 if a suitable vaccine becomes available or to get tested and self-isolate if they themselves have COVID-19 symptoms and whether the willingness could be influenced by the Greater Sydney lockdown 2021. Methods: A cross-sectional telephone survey was conducted between 24th February and 26th October 2021. Questions from the NSW Adult Population Health Survey and from previously published studies were used to assess family demographics, mothers' willingness to vaccinate their young children, and willingness to get tested and self-isolate if symptomatic. The survey involved 604 mothers of children aged 4 years who participated in an existing trial in Sydney, Australia. Results: Mothers were more willing to vaccinate their children when the child's father had a tertiary education or higher, with an adjusted odds ratio (AOR) of 2.60 (95% CI 1.67-4.04). Mothers who were older than 30 years or who completed the survey during the lockdown were more willing to get tested if symptomatic, with AOR 2.50 (95% CI 1.17-5.36) and AOR 3.36 (95% CI 1.41-8.02), respectively. Mothers who were married or had de-facto partners were more willing to self-isolate if symptomatic [AOR 17.15 (95% CI 3.56-82.65)]. Conclusion: Fathers' educational level, mothers' age, and marital status were associated with mothers' willingness to vaccinate their young children if a suitable vaccine were available, to get tested, and self-isolate if symptomatic respectively. The promotion of mitigation strategies for tackling the COVID-19 pandemic needs to take into account specific family demographics.