The economic burden of myalgic encephalomyelitis/chronic fatigue syndrome in Australia.

Objective This study aimed to estimate costs of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) to patients, government and Australian society. Methods Australian ME/CFS patients and their carers were recruited using convenience sampling. Patients completed an online retrospective cost diary, providing ME/CFS-related direct medical, non-medical and indirect costs. Informal care costs were collected directly from carers. Data from the Pharmaceutical Benefits Scheme and Medicare Benefits Schedule were linked to participant survey data. Annual per patient and total societal costs were estimated, broken down by category and presented in 2021 AUD. Factors associated with higher costs were investigated using generalised linear models. Results One hundred and seventy five patients (mean age 49 years s.d. 14, 79.4% female) completed the cost diary. Estimated total annual societal costs of ME/CFS in Australia ranged between $1.38 and $10.09 billion, with average annual total costs of $63 400/patient. Three-quarters of these costs were due to indirect costs ($46 731). Disability severity was the key factor associated with higher costs, particularly for indirect costs (being 2.27-fold higher for severe disability than no/mild disability). Conclusions ME/CFS poses a significant economic burden in Australia, owing mainly to high indirect and informal care costs.

The relative contribution of co-morbidities to health-related quality of life of people with idiopathic pulmonary fibrosis using the Assessment of Quality of Life-8-Dimension multi-attribute utility instrument.

PURPOSE: Little is known about the impact of co-morbidities on health-related quality of life (HRQoL) for people with idiopathic pulmonary fibrosis (IPF). We aimed to investigate the relative contribution of co-morbidities to HRQoL of people with IPF. METHODS: N = 157 participants were recruited from the Australian IPF Registry (AIPFR). Health state utilities (HSUs), and the super-dimensions of physical and psychosocial scores were measured using the Assessment of Quality of Life-8-Dimensions (AQoL-8D). The impact of co-morbidities on HRQoL was investigated using linear regression and general dominance analyses. RESULTS: A higher number of co-morbidities was associated with lower HSUs (p trend = 0.002). Co-morbidities explained 9.1% of the variance of HSUs, 16.0% of physical super-dimensional scores, and 4.2% of psychosocial super-dimensional scores. Arthritis was associated with a significant reduction on HSUs (ß = - 0.09, 95% confidence interval [CI] - 0.16 to - 0.02), largely driven by reduced scores on the physical super-dimension (ß = - 0.13, 95% CI - 0.20 to - 0.06). Heart diseases were associated with a significant reduction on HSUs (ß = - 0.09, 95% CI - 0.16 to - 0.02), driven by reduced scores on physical (ß = - 0.09, 95% CI - 0.16 to - 0.02) and psychosocial (ß = -0.10, 95% CI - 0.17 to - 0.02) super-dimensions. CONCLUSIONS: Co-morbidities significantly impact HRQoL of people with IPF, with markedly negative impacts on their HSUs and physical health. A more holistic approach to the care of people with IPF is important as better management of these co-morbidities could lead to improved HRQoL in people with IPF.

A Randomised Controlled Trial of YOGa and Strengthening Exercise for Knee OsteoArthritis: Protocol for a Comparative Effectiveness Trial (YOGA Trial).

Osteoarthritis (OA) is a common joint disorder for which there is no cure. Current treatments are suboptimal. Exercise is a core treatment for knee OA, with muscle strengthening exercise commonly recommended. Yoga is a mind-body exercise intervention that can improve flexibility, muscle strength, balance, and fitness and potentially reduce symptoms of OA. However, there is a scarcity of robust, high-quality conclusive evidence on the efficacy of yoga in knee OA. We are currently conducting the first randomised comparative effectiveness and cost-effectiveness trial of a yoga program compared with a strengthening exercise program in patients with symptomatic knee OA. This study protocol describes the design and conduct of this trial. The YOGA study is a phase III, single-centre, parallel, superiority, randomised, active-controlled trial which will be conducted in Hobart, Australia. One hundred and twenty-six participants (63 in each arm) aged over 40 years with symptomatic knee OA will be recruited from the community and randomly allocated to receive either a 24-week yoga program (3×/week) or a strengthening exercise program (3×/week). The primary outcome will be change in knee pain over 12 weeks, assessed using a 100 mm visual analogue scale (VAS). The secondary outcomes include change in knee pain, patient global assessment, physical function, quality of life, gait speed, biomarkers, and others over 12 and 24 weeks. We will also assess whether the presence of neuropathic pain moderates the effects of yoga compared to strengthening exercise. Additional data, such as cost and resource utilization, will be collected for the cost-effectiveness analysis. The primary analysis will be conducted using an intention-to-treat approach. Adverse events will be monitored throughout the study. Once completed, this trial will contribute to the knowledge of whether yoga can be used as a simple, effective, low-cost option for the management of knee OA, thus saving economic costs in the healthcare system.

Cost analysis of employing general practitioners within residential aged care facilities based on a prospective, stepped-wedge, cluster randomised trial.

OBJECTIVE: To assess the impacts of changing a model of care and employing general practitioners (GPs) within residential aged care facilities (RACFs) on costs to the aged care provider (ACP) and state and federal governments of Australia. METHODS: This study was a cost analysis of a prospective, stepped-wedge, cluster randomised trial. All financial data from the ACP for every RACF involved, before and after implementation of the new model were obtained. Costs of hospital transfers, admissions, ambulance usage and GP consultations were calculated. Costs of new infrastructure, recruiting and training new staff were accounted for. Costs were standardised to 2019 Australian Dollars per occupied bed day (OBD). RESULTS: Implementation of the new model of care resulted in overall cost savings of $9.7 per OBD to the ACP, with increased salary costs offset by increased federal government subsidies and Medicare claims income. Costs to the federal government increased by $19.6 per OBD, driven by increases in subsides. Costs savings of $3.0 per OBD to state governments were seen, driven by decreased costs of hospital transfers. CONCLUSIONS: Implementation of a model of care including GPs employed at RACFs had a mixed impact on costs depending on perspective, with overall savings to the ACP and state government perspective.

Preoperative physiotherapy is cost-effective for preventing pulmonary complications after major abdominal surgery: a health economic analysis of a multicentre randomised trial.

QUESTION: Is preoperative physiotherapy cost-effective in reducing postoperative pulmonary complications (PPC) and improving quality-adjusted life years (QALYs) after major abdominal surgery? DESIGN: Cost-effectiveness analysis from the hospitals' perspective within a multicentre randomised controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis. PARTICIPANTS: Four hundred and forty-one adults awaiting elective upper abdominal surgery attending pre-anaesthetic clinics at three public hospitals in Australia and New Zealand. INTERVENTIONS: The experimental group received an information booklet and a 30-minute face-to-face session, involving respiratory education and breathing exercise training, with a physiotherapist. The control group received the information booklet only. OUTCOME MEASURES: The probability of cost-effectiveness and incremental net benefits was estimated using bootstrapped incremental PPC and QALY cost-effectiveness ratios plotted on cost-effectiveness planes and associated probability curves through a range of willingness-to-pay amounts. Cost-effectiveness modelling utilised 21-day postoperative hospital cost audit data and QALYs estimated from Short Form-Six Domain health utilities and mortality to 12 months. RESULTS: Preoperative physiotherapy had 95% probability of being cost-effective with an incremental net benefit to participating hospitals of A$4,958 (95% CI 10 to 9,197) for each PPC prevented, given that the hospitals were willing to pay $45,000 to provide the service. Cost-utility for QALY gains was less certain. Sensitivity analyses strengthened cost-effectiveness findings. Improved cost-effectiveness and QALY gains were detected when experienced physiotherapists delivered the intervention. CONCLUSIONS: Preoperative physiotherapy aimed at preventing PPCs was highly likely to be cost-effective from the hospitals' perspective. For each PPC prevented, preoperative physiotherapy is likely to cost the hospitals less than the costs estimated to treat a PPC after surgery. Potential QALY gains require confirmation. TRIAL REGISTRATION: ACTRN12613000664741.

SF-6D health state utilities for lifestyle, sociodemographic and clinical characteristics of a large international cohort of people with multiple sclerosis.

BACKGROUND: While many studies have examined the impacts of multiple sclerosis (MS) on health-related quality of life (HRQoL), none have used the SF-6D multi-attribute utility instrument in a large international cohort (> 2000 subjects) of people with MS. OBJECTIVES: To derive SF-6D health state utilities (HSUs) for participants of the HOLISM (Health Outcomes and Lifestyle In a Sample of people with Multiple Sclerosis) international cohort and to describe the distribution and determinants thereof. METHODS: HSUs were generated using the SF-6D for participants with sufficient SF-36 data [n = 2185/2466 (88.6%)]. Mean HSUs for sociodemographic, clinical and modifiable lifestyle factors (including diet, physical activity, supplement use) were evaluated. Determinants of HSU were then evaluated by linear regression, adjusted for age, sex, MS type, disability, fatigue, and prescription antidepressant use. RESULTS: Mean HSU for the sample was 0.67 (SD = 0.13) and diminished with increasing MS-related disability, robust to adjustment, supporting the SF-6D's discriminatory power in people with MS. Severe disability and clinically significant fatigue were each associated with 11% lower HSU (95% CI = - 0.13, - 0.10 and - 0.12, - 0.10), and depression risk with 10%-lower HSU (95% CI = - 0.11, - 0.08). Employment, higher socioeconomic and married/partnered statuses, larger social-network size, greater physical activity, and vitamin D and omega-3 supplement use were associated with significantly higher HSU, and overweight/obese BMI and tobacco smoking with lower HSU. Age, sex, and education were not associated. CONCLUSION: Modifiable lifestyle factors including healthy diet, increased physical activity and supplement use were associated with higher HRQOL among people with MS. The SF-6D instrument revealed significant discriminatory power in this international cohort of people with MS.

A novel method for calculating prevalence of multiple sclerosis in Australia.

OBJECTIVES: The purpose of this study was to determine the prevalence of multiple sclerosis (MS) in Australia in 2010 using a novel method based on Australia-wide prescription data for MS-specific disease modifying agents. The results obtained were validated against two other prevalence estimates. METHODS: We obtained the total number of scripts for medications that were used exclusively for the treatment of MS written in Australia for the period January-December 2010. The percentage of MS patients using medications (42-55%) was taken from state-specific surveys of MS Society clients. To estimate prevalence we divided the annual number of scripts dispensed by 12 and adjusted for penetration of medications by state. RESULTS: The prevalence of MS in Australia in 2010 calculated using the prescription method was 21,283 people (95.5/100,000). This compared to 21,200 people (95.2/100,000) obtained from the Australian Bureau of Statistics (ABS) Survey of Disability, Ageing and Carers (SDAC) survey of 2009 and 20,471 people (91.9/100,000) using MS Society client numbers. Prevalence increased with increasing latitude, with the prevalence for Tasmania over seven times that of the Northern Territory. Results were sensitive to the percentage of people with MS being treated. CONCLUSIONS: Calculation of prevalence of MS using nation-wide prescription data is a novel method that generates results similar to other potentially more resource-intensive methods.

The role of ω-3 fatty acid supplemented parenteral nutrition in critical illness in adults: a systematic review and meta-analysis.

OBJECTIVE: To determine whether the supplementation of parenteral nutrition with ω-3 fatty acids confers treatment benefits to critically ill adult patients. DATA SOURCE: We performed computerized searches for relevant articles from 1996 to June 2011 on MEDLINE, EMBASE, and the Cochrane register of controlled trials and abstracts of scientific meetings from 2005 to 2011. STUDY SELECTION: Randomized controlled trials of ω-3 fatty acid supplemented parenteral nutrition in critically ill adult patients admitted to the intensive therapy unit, given in addition to their routine care, compared with parenteral nutrition without ω-3 fatty acid supplementation. DATA SYNTHESIS: Five fully published trials and three trials published in abstract form with 391 participants have been included. Overall trial quality was poor. Mortality data were pooled from eight studies with 391 participants. No differences were found with a risk ratio for death of 0.83 (95% confidence interval 0.57, 1.20; p = 0.32). Data for infectious complications were available from five studies with 337 participants. No differences were found, with a risk ratio for infection of 0.78 (95% confidence interval 0.43, 1.41; p = 0.41). Data for intensive therapy unit and hospital length of stay were available from six and three studies with 305 and 117 participants, respectively. With respect to intensive therapy unit length of stay, no differences were observed with a mean difference of 0.57 days in favor of the ω-3 fatty acid group (95% confidence interval -5.05, 3.90; p = 0.80). A significant reduction in hospital length of stay of 9.49 days (95% confidence interval -16.51, -2.47; p = 0.008) was observed for those receiving ω-3 fatty acid supplemented parenteral nutrition, but results were strongly influenced by one small study. CONCLUSIONS: On the basis of this systematic review, it can be concluded that ω-3 fatty acid supplementation of parenteral nutrition does not improve mortality, infectious complications, and intensive therapy unit length of stay in comparison with standard parenteral nutrition. Although ω-3 fatty acids appear to reduce hospital length of stay, the poor methodology of the included studies and the absence of other outcome improvements mean they cannot be presently recommended.

Acarbose in addition to existing treatments in patients with type 2 diabetes: health economic analysis in a German setting.

OBJECTIVE: A recent retrospective meta-analysis of cardiovascular events from long-term studies with acarbose in type 2 diabetes showed that treatment was associated with a significant reduction in the risk of cardiovascular events, supporting the hypothesis that postprandial hyperglycemia is a risk factor for cardiovascular disease. The aim of the present study was to assess the cost-effectiveness of acarbose, given in addition to existing treatments, in type 2 diabetes patients, based on these findings, in the German setting. METHODS: The CORE Diabetes Model, a published, validated computer simulation model, was used to project long-term clinical and cost outcomes in type 2 diabetes patients receiving acarbose or placebo in addition to existing treatments. Direct costs were retrieved from published sources and projected over patient lifetimes from a third party payer perspective. Costs and clinical benefits were discounted at 5% annually. Extensive sensitivity analyses were performed. RESULTS: Acarbose treatment was associated with improvements in discounted life expectancy (0.21 years) and quality-adjusted life expectancy (QALE) (0.19 QALYs) but was on average marginally more expensive than treatment in the placebo arm (euro135 per patient). This led to incremental cost-effectiveness ratios of euro633 per life year and euro692 per quality-adjusted life year gained. Sensitivity analysis showed that these findings were robust under variation in a range of assumptions. CONCLUSIONS: Addition of acarbose to existing treatment was associated with improvements in life expectancy and quality-adjusted life expectancy, and provides excellent value for money over patient lifetimes in the German setting.