Prioritising patients for publicly funded bariatric surgery in Queensland, Australia.

OBJECTIVES: This study reports the development and pilot application of the Bariatric Surgery Assessment and Prioritisation Tool (BAPT) for use in a public health system. The BAPT was designed as a patient prioritisation instrument to assess patients with excessive weight and type 2 diabetes suitable for bariatric surgery. We assessed whether the instrument successfully identified those who gained the greatest benefits including weight loss, diabetes remission, reduction in comorbidities, and health-related quality of life (HR-QoL). METHODS: The BAPT instrument was applied to score 292 patients referred for bariatric surgery in Queensland between 2017 and 2020 based on their, body mass index, diabetes status, surgical risk (e.g. pulmonary embolism) and comorbidities (e.g. non-alcoholic steatohepatitis). These data were collected at referral and at 12-months post-surgery for 130 patients and stratified by BAPT scores. Outcomes included clinical and HR-QoL. RESULTS: Patients' BAPT scores ranged from 12 to 78 (possible range 2-98). Those with higher scores tended to be younger (p < 0.001), have higher BMI (p < 0.001) or require insulin to manage diabetes (p < 0.01). All patients lost similar percentages of body weight (20-25%, p = 0.73) but higher-scoring patients were more likely to discontinue oral diabetes medications (p < 0.001) and the improvement in glycated haemoglobin was four times greater in patients scoring 70-79 points compared to those scoring 20-29 (p < 0.05). Those who scored ≥ 50 on the BAPT were substantially more likely to obtain diabetes remission (57% vs 31%). BAPT scores of 40 and above tended to have greater improvement in HR-QoL. CONCLUSIONS: The BAPT prioritised younger patients with higher BMIs who realised greater improvements in their diabetes after bariatric surgery. Higher-scoring BAPT patients should be prioritised for bariatric surgery as they have a greater likelihood of attaining diabetes remission.

Economic evaluation of personalized vs. standard dosing of 5-fluorouracil in first-line chemotherapy for metastatic colorectal cancer in Australia.

AIMS: Using pharmacokinetics (PK)-guided 5-fluorouracil (5-FU) for metastatic colorectal cancer (mCRC) improves overall survival (OS) and decreases toxicity, yet its value for money in the Australian setting is unknown. Our study assesses the cost-effectiveness of PK vs. body surface area (BSA) dosing of 5-FU for patients with mCRC. METHODS: We developed a semi-Markov model with four health states to compare PK-guided dosing within a FOLFOX regimen vs. BSA-guided dosing for mCRC patients from an Australian healthcare system perspective. Transition probabilities were derived from fitted survival models, with utility values obtained directly from published studies. We calculated direct healthcare costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs), and included both one-way and probabilistic sensitivity analyses. RESULTS: BSA-guided FOLFOX provided 1.291 QALYs at a cost of $36 379, compared with PK-guided FOLFOX which delivered 1.751 QALYs at a cost of $32 564. Therefore, PK-guided dosing emerges as the dominant strategy offering both better health outcomes and lower costs. The variables that had the greatest impact on the overall ICER were the adverse event rates in the BSA and PK groups, model time horizon, utility of progression-free survival and PREDICT assay cost. Our univariate and multivariate sensitivity analysis confirmed that the ICER for PK FOLFOX consistently remained below $50 000 per QALY across all tested variables. CONCLUSIONS: PK dose management of 5-FU-based chemotherapy in mCRC patients appears to be a cost-saving strategy in Australia. However, our model estimates are drawn from limited, low-quality evidence. Further evidence from randomized controlled trials (RCTs), directly comparing PK-based to BSA-based dosing across a variety of current regimens, is needed to address our model's uncertainties.

Development of a Prioritization Framework to Aid Healthcare Funding Decision Making in Health Technology Assessment in Australia: Application of Multicriteria Decision Analysis.

OBJECTIVES: This study develops a prioritization framework to aid healthcare funding decision making in health technology assessment (HTA) in Australia using a multiple criteria decision analysis (MCDA) approach. METHODS: MCDA frameworks for HTAs were reviewed through literature survey to identify the initial criteria and levels within each criterion. Key stakeholders and experts were consulted to confirm these criteria and levels. A conjoint analysis using 1000Minds was undertaken with policy makers from the Department of Health to establish ranking criteria and weighting scores. Monte Carlo simulations were used to examine the sensitivity of findings to factors affecting the ranking and weighting scores. The MCDA was then applied to 6 examples of chronic care models or technologies projects to demonstrate the performance of this approach. RESULTS: Five criteria (clinical efficacy/effectiveness, safety and tolerability, severity of the condition, quality/uncertainty, and direct impact on healthcare costs) were consistently ranked highest by healthcare decision makers. Among the criteria, patient-level health outcomes were considered the most important, followed by social and ethical values. The analyses were robust to inform the uncertainty in the parameter. CONCLUSIONS: This study has developed an MCDA tool that effectively integrates key priorities for HTA reviews, reflecting the values and preferences of healthcare stakeholders in Australia. Although this tool aims to align the assessment process more closely with health benefits, it also highlights the importance of considering other criteria.

The Cost-Effectiveness of Germline BReast CAncer Gene Testing in Metastatic Prostate Cancer Followed by Cascade Testing of First-Degree Relatives of Mutation Carriers.

OBJECTIVES: Patients with metastatic prostate cancer (mPCa) with BReast CAncer gene (BRCA) mutations benefit from targeted treatments (eg, olaparib). In addition, family members of affected patients have increased risk of hereditary cancers and benefit from early detection and prevention. International guidelines recommend genetic testing in mPCa; however, the value for money of testing patients with mPCa and cascade testing of blood-related family members has not been assessed. In this context, we evaluated the cost-effectiveness of germline BRCA testing in patients with mPCa followed by cascade testing of first-degree relatives (FDRs) of mutation carriers. METHODS: We conducted a cost-utility analysis of germline BRCA testing using 2 scenarios: (1) testing patients with mPCa only and (2) testing patients with mPCa and FDRs of those who test positive. A semi-Markov multi-health-state transition model was constructed using a lifetime time horizon. The analyses were performed from an Australian payer perspective. Decision uncertainty was characterized using probabilistic analyses. RESULTS: Compared with no testing, BRCA testing in mPCa was associated with an incremental cost of AU$3731 and a gain of 0.014 quality-adjusted life-years (QALYs), resulting in an incremental cost-effectiveness ratio of AU$265 942/QALY. Extending testing to FDRs of variant-positive patients resulted in an incremental cost-effectiveness ratio of AU$16 392/QALY. Probability of cost-effectiveness at a willingness-to-pay of AU$75 000/QALY was 0% in the standalone mPCa analysis and 100% in the cascade testing analysis. CONCLUSION: BRCA testing when performed as a standalone strategy in patients with mPCa may not be cost-effective but demonstrates significant value for money after the inclusion of cascade testing of FDRs of mutation carriers.

Health care resource use in preschool children with cerebral palsy.

AIM: To estimate the burden of disease and evaluate which factors affect health care resource use (HCRU) in young children with cerebral palsy (CP). METHOD: Data were collected as part of a prospective, longitudinal cohort study of children with CP born in Queensland, Australia between 2006 and 2009. HCRU questionnaires were administered at six time points. Data on resource use, socio-demographics, and disease severity were collected. Costs were sourced from Medicare, the Australian National Hospital Cost Data Collection, and market prices. A generalized linear model was used to identify factors influencing CP-related costs. RESULTS: A total of 794 questionnaires were completed by 222 participants (mean = 3.6 per participant). Physiotherapy (94%, n = 208) was the most widely accessed allied health care therapy; almost half of the participants (45%; 354 of 794) reported one or more hospital admissions. From the health care funder perspective, a child with CP costs on average A$24 950 per annum (A$12 475 per 6 months). Higher costs were associated with increased motor impairment (Gross Motor Function Classification System, p < 0.001) and increased comorbidities (p = 0.012). INTERPRETATION: HCRU in preschool children with CP can be analysed according to disease severity. Both increased motor impairments and increased comorbidities were associated with higher health care costs.

The cost-effectiveness of germline BRCA testing-guided olaparib treatment in metastatic castration resistant prostate cancer.

BACKGROUND: Olaparib targets the DNA repair pathways and has revolutionized the management of metastatic castration resistant prostate cancer (mCRPC). Treatment with the drug should be guided by genetic testing; however, published economic evaluations did not consider olaparib and genetic testing as codependent technologies. This study aims to assess the cost-effectiveness of BRCA germline testing to inform olaparib treatment in mCRPC. METHODS: We conducted a cost-utility analysis of germline BRCA testing-guided olaparib treatment compared to standard care without testing from an Australian health payer perspective. The analysis applied a decision tree to indicate the germline testing or no testing strategy. A Markov multi-state transition approach was used for patients within each strategy. The model had a time horizon of 5 years. Costs and outcomes were discounted at an annual rate of 5 percent. Decision uncertainty was characterized using probabilistic and scenario analyses. RESULTS: Compared to standard care, BRCA testing-guided olaparib treatment was associated with an incremental cost of AU$7,841 and a gain of 0.06 quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio (ICER) was AU$143,613 per QALY. The probability of BRCA testing-guided treatment being cost effective at a willingness-to-pay threshold of AU$100,000 per QALY was around 2 percent; however, the likelihood for cost-effectiveness increased to 66 percent if the price of olaparib was reduced by 30 percent. CONCLUSION: This is the first study to evaluate germline genetic testing and olaparib treatment as codependent technologies in mCRPC. Genetic testing-guided olaparib treatment may be cost-effective with significant discounts on olaparib pricing.

Religious Belief Among Women in Australia: Characteristics and Role in Influencing Children's Health-Related Quality of Life and Lifestyle.

Religiosity can be an important factor in women's health-related behaviour, attitudes, and decision-making. Evidence however, regarding the religiosity of mothers and its influence on child health, is scarce. Based on a large population-based cohort in Australia, we aim to examine the religiosity of women in Australia and the association of maternal religiosity with children's health-related quality of life (HRQOL) and lifestyle. Our findings indicate that (1) maternal religious involvement was higher for women with higher education levels, ascertained religious values in decision-making, and abstinence from binge drinking in the household, (2) maternal religiosity positively influenced their children's HRQOL, (3) children of mothers who were more religious had less worries or fewer school-work problems, but the children of mothers with stronger religious beliefs used more internet/computer during the week but had less time playing games on weekends. This study provides additional specificity to inform future health interventions in religious community contexts to enhance the positive influence of maternal religious belief for better development of their children.

Testing for selection bias and moral hazard in private health insurance: Evidence from a mixed public-private health system.

Separating selection bias from moral hazard in private health insurance (PHI) markets has been a challenging task. We estimate selection bias and moral hazard in Australia's mixed public-private health system, where PHI premiums are community-rated rather than risk-rated. Using longitudinal cohort data, with fine-grained measures for medical services predominantly funded by PHI providers, we find consistent and robust estimates of advantageous selection among hospitalized cardiovascular disease (CVD) patients. Specifically, we show that in addition to their risk-averse attributes, CVD patients who purchase PHI use fewer services that are not covered by PHI providers (e.g., general practitioners and emergency departments) and have fewer comorbidities. Finally, unlike previous studies, we show that ex-post moral hazard exists in the use of specific "in-hospital" medical services such as specialist and physician services, miscellaneous diagnostic procedures, and therapeutic treatments. From the perspective of PHI providers, the annual cost of moral hazard translates to a lower bound estimate of $707 per patient, equivalent to a 3.03% reduction in their annual profits.

An overview of reproductive carrier screening panels for autosomal recessive and/or X-linked conditions: How much do we know?

BACKGROUND & AIM: Reproductive carrier screening seeks to identify couples at a high risk of having offspring affected by autosomal recessive and X-linked (XL) conditions. The aim of this paper is to provide a comprehensive overview of existing carrier screening panels by examining their gene content and characteristics, identifying the most common genes/conditions included in these panels, and analyzing their listed prices. METHODS: A comprehensive evaluation of existing carrier screening panels was conducted by searching for web-based content, reviewing information brochures, and establishing direct contact with the providers via email or phone. RESULTS: Twenty-two panels and their providers were identified with a cumulative total of 2205 unique genes. The number of genes included in these panels varied from 44 to 2054. Only 15 genes (0.7%) were included in all the panels. The carrier frequency of these 15 common genes and their associated conditions varied greatly, but the conditions associated with the genes are "severe". The price of these 22 panels ranged from $349 to $4320 per couple (USD in 2023). The correlation between the listed price and the number of selected genes among these panels was small and not statistically significant (r = 0.1023, p = 0.6959). CONCLUSION: Considerable discrepancies exist among carrier screening panels. Ongoing research and monitoring are necessary to capture the dynamic nature of the carrier screening landscape, providing up-to-date information for clinical practice and informed decision-making.

Institutionalizing health technology assessment in Ethiopia: seizing the window of opportunity.

Ethiopia's commitment to achieving universal health coverage (UHC) requires an efficient and equitable health priority-setting practice. The Ministry of Health aims to institutionalize health technology assessment (HTA) to support evidence-based decision making. This commentary highlights key considerations for successful formulation, adoption, and implementation of HTA policies and practices in Ethiopia, based on a review of international evidence and published normative principles and guidelines. Stakeholder engagement, transparent policymaking, sustainable financing, workforce education, and political economy analysis and power dynamics are critical factors that need to be considered when developing a national HTA roadmap and implementation strategy. To ensure ownership and sustainability of HTA, effective stakeholder engagement and transparency are crucial. Regulatory embedding and sustainable financing ensure legitimacy and continuity of HTA production, and workforce education and training are essential for conducting and interpreting HTA. Political economy analysis helps identify opportunities and constraints for effective HTA implementation. By addressing these considerations, Ethiopia can establish a well-designed HTA system to inform evidence-based and equitable resource allocation toward achieving UHC and improving health outcomes.

A baseline profile of the Queensland Cardiac Record Linkage Cohort (QCard) study.

BACKGROUND: Cardiovascular disease (CVD) is one of the leading causes of death in Australia. Longitudinal record linkage studies have the potency to influence clinical decision making to improve cardiac health. This paper describes the baseline characteristics of the Queensland Cardiac Record Linkage Cohort study (QCard). METHODS: International Classification of Disease, 10th Revision Australian Modification (ICD-10-AM) diagnosis codes were used to identify CVD and comorbidities. Cost and adverse health outcomes (e.g., comorbidities, hospital-acquired complications) were compared between first-time and recurrent admissions. Descriptive statistics and standard tests were used to analyse the baseline data. RESULTS: There were 132,343 patients with hospitalisations in 2010, of which 47% were recurrent admissions, and 53% were males. There were systematic differences between characteristics of recurrent and first-time hospitalisations. Patients with recurrent episodes were nine years older (70 vs. 61; p < 0.001) and experienced a twice higher risk of multiple comorbidities (3.17 vs. 1.59; p < 0.001). CVD index hospitalisations were concentrated in large metropolitan hospitals. CONCLUSIONS: Our study demonstrates that linked administrative health data provide an effective tool to investigate factors determining the progress of heart disease. Our main finding suggests that recurrent admissions were associated with higher hospital costs and a higher risk of having adverse outcomes.

Exercise in preventing falls for men with prostate cancer: a modelled cost-utility analysis.

INTRODUCTION: Men who receive androgen deprivation therapy (ADT) for prostate cancer (PCa) are a vulnerable falls population due to the side effects of treatment. The purpose of this paper is to determine the cost-effectiveness of exercise in preventing falls and fractures for this high-risk population in Australia. METHODS: A decision analytic model was constructed to evaluate the cost utility of an exercise intervention compared to usual care from a health system perspective. The intervention comprised two 1-h sessions of supervised exercise per week over 1 year for men with non-metastatic PCa receiving curative radiation therapy and ADT. A Markov model simulated the transition between five health states: (1) at risk of falling; (2) at recurrent risk of falling; (3) fracture (minor or major); (4) non-fracture injury (minor or major); and (5) death. Model inputs including transition probabilities and utility scores were obtained from published meta-analyses, and costs were drawn from Australian data sources (e.g. Medical Benefits Schedule). The model time horizon was 3 years, and costs and effects were discounted at 5% annual rate. Costs and quality-adjusted life years (QALYs) were aggregated and compared between the intervention and control to calculate incremental net monetary benefit (iNMB). Uncertainty in the results was explored using deterministic and probabilistic sensitivity analyses (PSA). RESULTS: At a willingness-to-pay of AU$50,000 per QALY, the exercise intervention dominated, as it was less costly and more effective than usual care. The iNMB was $3010 per patient. The PSA showed a 58% probability the intervention was cost-effective. CONCLUSION: This is the first modelled economic evaluation of exercise for men with PCa. Our results suggest supervised exercise is cost-effective in reducing the risks of falls and fractures in this population.

Development of a preference-based heart disease-specific health state classification system using MacNew heart disease-related quality of life instrument.

PURPOSE: The MacNew Heart Disease Health-Related Quality of Life Instrument (MacNew) is a validated, clinically sensitive, 27-item disease-specific questionnaire. This study aimed to develop a new heart disease-specific classification system for the MacNew amenable for use in health state valuation. METHODS: Patients with heart disease attending outpatient clinics and inpatient wards in Brisbane, Australia, completed MacNew. The development of the new disease-specific classification system included three stages. First, a principal component analysis (PCA) established dimensionality. Second, Rasch analysis was used to select items for each dimension. Third, Rasch analysis was used to explore response-level reduction. In addition, clinician and patient judgement informed item selection. RESULTS: Participants included 685 patients (acute coronary 6%, stable coronary 41%, chronic heart failure 20%). The PCA identified 4 dimensions (restriction, emotion, perception of others, and symptoms). The restriction dimension was divided into physical and social dimensions. One item was selected from each to be included in the classification system. Three items from the emotional dimension and two symptom items were also selected. The final classification system had seven dimensions with four severity levels in each: physical restriction; excluded from doing things with other people; worn out or low in energy; frustrated, impatient or angry; unsure and lacking in self-confidence; shortness of breath; and chest pain. CONCLUSION: This study generated a brief heart disease-specific classification system, consisting of seven dimensions with four severity levels in each. The classification system is amenable to valuation to enable the generation of utility value sets to be developed for use in economic evaluation.

Cost-effectiveness of combined catheter ablation and left atrial appendage closure for symptomatic atrial fibrillation in patients with high stroke and bleeding risk.

BACKGROUND: Combined catheter ablation (CA) and left atrial appendage closure (LAAC) have been proposed for management of symptomatic atrial fibrillation (AF) in patients with high stroke and bleeding risk. We assessed the cost-effectiveness of combined CA and LAAC compared with CA and standard oral anticoagulation (OAC) in symptomatic AF. METHODS: A Markov model was developed to assess total costs, quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio among 2 post-CA strategies: (1) standard OAC and (2) LAAC (combined CA and LAAC procedure). The base-case used a 10-year time horizon and consisted of a hypothetical cohort of patients aged 65 years with symptomatic AF, with high thrombotic (CHA2DS2-VASc = 3) and bleeding risk (HAS-BLED = 3), and planned for AF ablation. Values for transition probabilities, utilities, and costs were derived from the literature. Costs were converted to 2020 US dollars. Half-cycle correction was applied, and costs and QALYs were discounted at 3% annually. Sensitivity analyses were performed for significant variables and scenario analyses for higher embolic risk. RESULTS: In the base-case cohort of 10,000 patients followed for 10 years, total costs for the LAAC strategy were $29,027 and for OAC strategy were $27,896. The LAAC strategy was associated with 122 fewer disabling strokes and 203 fewer intracranial hemorrhages per 10,000 patients compared with the OAC strategy. The LAAC strategy had an incremental cost-effectiveness ratio of $11,072/QALY. In sensitivity analyses, although cost-effectiveness was highly dependent on the risk of intracranial hemorrhage in the LAAC strategy and the cost of the combined procedure, LAAC was superior to OAC under the most circumstances. Scenario analyses demonstrated that the combined procedure was more cost-effective in patients with higher stroke risk. CONCLUSIONS: In symptomatic AF patients with high stroke and bleeding risk who are planned for CA, the combined CA and LAAC procedure may be a cost-effective therapeutic option and be more beneficial to patients with CHA2DS2-VASc risk score ≥3.

A comprehensive review of economic evaluations of therapeutic drug monitoring interventions for cancer treatments.

Therapeutic drug monitoring (TDM) of cancer drugs has been shown to improve treatment effectiveness and safety. The aim of this paper was to comprehensively review economic evaluations of TDM interventions for cancer drugs. Searches were conducted in 4 electronic databases, Medline, EMBASE, and Centre for Reviews and Dissemination databases (Database of Abstracts of Reviews of Effects and the NHS Economic Evaluation Database), from their inception to June 2019. Studies were included if they were economic evaluations of TDM interventions for an active cancer treatment. The quality of reporting of economic evaluations was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS checklist). Of the 11 publications identified, imatinib with TDM and 5-fluorouracil with TDM were the most commonly assessed interventions (4 publications each). Overall study quality was good, with publications meeting 61 to 91% (median 80%) of CHEERS checklist criteria. A variety of studies were used to estimate the clinical effectiveness inputs for the cost effectiveness models. All publications considered TDM to be cost-effective based on an incremental cost-effectiveness ratio below the willingness to pay threshold (64%) or being cost-saving (36%). TDM interventions were considered cost-effective across the economic evaluations. Further clinical research assessing the impact of TDM on overall survival or other long-term health outcomes may enhance the evidence base for TDM in oncology. Future economic evaluations of TDM should explicitly consider uncertainty in the underlying clinical evidence and incorporate changes in the use of newer targeted drugs that form the current standard of care.

Cost-Effectiveness of Medicinal Cannabis for Management of Refractory Symptoms Associated With Chronic Conditions: A Systematic Review of Economic Evaluations.

OBJECTIVES: Although there is a growing body of evidence suggesting that cannabinoids may relieve symptoms of some illnesses, they are relatively high-cost therapies compared with illicit growth and supply. This article aimed to comprehensively review economic evaluations of medicinal cannabis for alleviating refractory symptoms associated with chronic conditions. METHODS: Seven electronic databases were searched for articles published up to September 6, 2020. The quality of reporting of economic evaluations was assessed using the Consolidated Health Economic Evaluation Reporting Standards checklist. The extracted data were grouped into subcategories according to types of medical conditions, organized into tables, and reported narratively. RESULTS: This review identified 12 cost-utility analyses conducted across a variety of diseases including multiple sclerosis (MS) (N = 8), pediatric drug-resistant epilepsies (N = 2), and chronic pain (N = 2). The incremental cost-effectiveness ratio varied widely from cost saving to more than US$451 800 per quality-adjusted life-year depending on the setting, perspectives, types of medicinal cannabis, and indications. Nabiximols is a cost-effective intervention for MS spasticity in multiple European settings. Cannabidiol was found to be a cost-effective for Dravet syndrome in a Canadian setting whereas a cost-utility analysis conducted in a US setting deemed cannabidiol to be not cost-effective for Lennox-Gastaut syndrome. Overall study quality was good, with publications meeting 70% to 100% (median 83%) of the Consolidated Health Economic Evaluation Reporting Standards checklist criteria. CONCLUSIONS: Medicinal cannabis-based products may be cost-effective treatment options for MS spasticity, Dravet syndrome, and neuropathic pain, although the literature is nascent. Well-designed clinical trials and health economic evaluations are needed to generate adequate clinical and cost-effectiveness evidence to assist in resource allocation.

Hospital frailty risk score and adverse health outcomes: evidence from longitudinal record linkage cardiac data.

BACKGROUND: Despite recent evidence on the effect of frailty on health outcomes among those with heart failure, there is a dearth of knowledge on measuring frailty using administrative health data on a wide range of cardiovascular diseases (CVD). METHODS: We conducted a retrospective record-linkage cohort study of patients with diverse CVD in Queensland, Australia. We investigated the relationship between the risk of frailty, defined using the hospital frailty risk score (HFRS), and 30-day mortality, 30-day unplanned readmission, non-home discharge, length of hospital stay (LOS) at an emergency department and inpatient units and costs of hospitalisation. Descriptive analysis, bivariate logistic regression and generalised linear models were used to estimate the association between HFRS and CVD outcomes. Smear adjustment was applied to hospital costs and the LOS for each frailty risk groups. RESULTS: The proportion of low, medium and high risk of frailty was 24.6%, 34.5% and 40.9%, respectively. The odds of frail patients dying or being readmitted within 30 days of discharge was 1.73 and 1.18, respectively. Frail patients also faced higher odds of LOS, and non-home discharge at 3.1 and 2.25, respectively. Frail patients incurred higher hospital costs (by 42.7-55.3%) and stayed in the hospital longer (by 49%). CONCLUSION: Using the HFRS on a large CVD cohort, this study confirms that frailty was associated with worse health outcomes and higher healthcare costs. Administrative data should be more accessible to research such that the HFRS can be applied to healthcare planning and patient care.

Excess mortality at Christmas due to cardiovascular disease in the HUNT study prospective population-based cohort in Norway.

BACKGROUND: Although it is known that winter inclusive of the Christmas holiday period is associated with an increased risk of dying compared to other times of the year, very few studies have specifically examined this phenomenon within a population cohort subject to baseline profiling and prospective follow-up. In such a cohort, we sought to determine the specific characteristics of mortality occuring during the Christmas holidays. METHODS: Baseline profiling and outcome data were derived from a prospective population-based cohort with longitudinal follow-up in Central Norway - the Trøndelag Health (HUNT) Study. From 1984 to 1986, 88% of the target population comprising 39,273 men and 40,353 women aged 48 ± 18 and 50 ± 18 years, respectively, were profiled. We examined the long-term pattern of mortality to determine the number of excess (all-cause and cause-specific) deaths that occurred during winter overall and, more specifically, the Christmas holidays. RESULTS: During 33.5 (IQR 17.1-34.4) years follow-up, 19,879 (50.7%) men and 19,316 (49.3%) women died at age-adjusted rate of 5.3 and 4.6 deaths per 1000/annum, respectively. Overall, 1540 (95% CI 43-45 deaths/season) more all-cause deaths occurred in winter (December to February) versus summer (June to August), with 735 (95% CI 20-22 deaths per season) of these cardiovascular-related. December 25th-27th was the deadliest 3-day period of the year; being associated with 138 (95% CI 96-147) and 102 (95% CI 72-132) excess all-cause and cardiovascular-related deaths, respectively. Accordingly, compared to 1st-21st December (equivalent winter conditions), the incidence rate ratio of all-cause mortality increased to 1.22 (95% CI 1.16-1.27) and 1.17 (95% 1.11-1.22) in men and women, respectively, during the next 21 days (Christmas/New Year holidays). All observed differences were highly significant (P < 0.001). A less pronounced pattern of mortality due to respiratory illnesses (but not cancer) was also observed. CONCLUSION: Beyond a broader pattern of seasonally-linked mortality characterised by excess winter deaths, the deadliest time of year in Central Norway coincides with the Christmas holidays. During this time, the pattern and frequency of cardiovascular-related mortality changes markedly; contrasting with a more stable pattern of cancer-related mortality. Pending confirmation in other populations and climates, further research to determine if these excess deaths are preventable is warranted.

Measuring psychosocial outcomes of men living with prostate cancer: feasibility of regular assessment of patient-reported outcomes.

OBJECTIVE: To trial collecting patient-reported outcome measures (PROMs) to assess psychosocial outcomes in men with prostate cancer (PC). METHODS: A cross-sectional postal survey was sent to three groups of 160 men with PC (6, 12 and 24 months post-initial treatment; ntotal  = 480), through the South Australian Prostate Cancer Clinical Outcomes Collaborative (SAPCCOC) registry (2017). Outcomes were as follows: response rate, completeness, general and disease-specific quality of life, distress, insomnia, fear of recurrence, decisional difficulties and unmet need. RESULTS: A response rate of 57-61% (n = 284) was achieved across groups. Data completeness was over 90% for 88% of survey items, with lower response (76-78%) for EPIC-26 urinary and sexual functioning subscales, sexual aid use (78%) and physical activity (68%). In general, higher socio-economic indicators were associated with higher completion of these measures (absolute difference 12-26%, p < 0.05). Lower unmet need on the sexuality domain (SCNS-SF34) was associated with lower completion of the EPIC-26 sexual functioning subscale [M (SD) = 12.4 (21.6); M (SD) = 26.3 (27.3), p < .001]. Worse leaking urine was associated with lower completion of urinary pad/diaper use question (EPIC-26) [M (SD) = 65.9 (26.5), M (SD) = 77.3 (23.9), p < .01]. CONCLUSION: Assessment of psychosocial PROMs through a PC registry is feasible and offers insight beyond global quality of life assessment, to facilitate targeting and improvements in services and treatments.

The Baby Steps Web Program for the Well-Being of New Parents: Randomized Controlled Trial.

BACKGROUND: New parents face increased risks of emotional distress and relationship dissatisfaction. Digital interventions increase support access, but few preventive programs are optimized for both parents. OBJECTIVE: This study aims to conduct the first randomized controlled trial on universal self-guided digital programs to support positive perinatal adjustment of both mothers and fathers. Effects of childcare information (Baby Care) and information plus an interactive program (Baby Steps Wellbeing) were compared from the third trimester baseline to 3 and 6 months subsequently. METHODS: The study recruited 388 co-parenting male-female adult couples expecting their first single child (26-38 weeks' gestation), using web-based registration. Most (337/388, 86.8%) were obtained from prenatal hospital classes. Couples' randomization was automated and stratified by Edinburgh Postnatal Depression Scale (EPDS) scores (50% couples scored high if either mother >7, father >5). All assessments were web-based self-reports: the EPDS and psychosocial quality of life were primary outcomes; relationship satisfaction, social support, and self-efficacy for parenting and support provision were secondary. Linear mixed models provided intention-to-treat analyses, with linear and quadratic effects for time and random intercepts for participants and couples. RESULTS: Selection criteria were met by 63.9% (248/388) of couples, who were all randomized. Most participants were married (400/496, 80.6%), tertiary educated (324/496, 65.3%), employed full time (407/496, 82%), and born in Australia (337/496, 67.9%). Their mean age was 32.2 years, and average gestation was 30.8 weeks. Using an EPDS cutoff score of 13, 6.9% (18/248) of men, and 16.1% (40/248) of women screened positive for depression at some time during the 6 months. Retention of both partners was 80.6% (201/248) at the 6-month assessments, and satisfaction with both programs was strong (92% ≥50). Only 37.3% (185/496) of participants accessed their program more than once, with higher rates for mothers (133/248, 53.6%) than fathers (52/248, 20.9%; P<.001). The EPDS, quality of life, and social support did not show differential improvements between programs, but Baby Steps Wellbeing gave a greater linear increase in self-efficacy for support provision (P=.01; Cohen d=0.26) and lower reduction in relationship satisfaction (P=.03; Cohen d=0.20) than Baby Care alone. Mothers had greater linear benefits in parenting self-efficacy over time than fathers after receiving Baby Steps Wellbeing rather than Baby Care (P=.01; Cohen d=0.51). However, the inclusion of program type in analyses on parenting self-efficacy and relationship satisfaction did not improve model fit above analyses with only parent gender and time. CONCLUSIONS: Three secondary outcomes showed differential benefits from Baby Steps Wellbeing, but for one (parenting self-efficacy), the effect only occurred for mothers, perhaps reflecting their greater program use. Increased engagement will be needed for more definitive testing of the potential benefits of Baby StepsWellbeing for perinatal adjustment. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614001256662; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367277.