Economic Evaluation and health outcomes measurement |
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A group-randomised trial of three models of nursing care for dementia patients in residential aged careKey Objectives This study compares the care of dementia patients in 3 different scenarios: - DCM involves detailed observations of patient’s well-being and behavioural disturbances. Feedback is given to staff in a bid to improve patient care; - PCC regards the patient as an equal partner with healthcare professionals. All treatment decisions are made with respect to the person’s overall well-being. Patient care is monitored to ensure individuals receive the most appropriate treatment from all agencies; - Usual care. The study involving 289 aged care residents with dementia and 194 care staff in 15 dementia care units aims to investigate the effect of DCM and PCC on: - resident quality of life and behavioural disturbance, - staff stress, job satisfaction, and turnover rates, - quality of care, - cost of care. DCM is very labour and time intensive. The researchers are interested in exploring the extent to which PCC, which is less labour intensive, may also lead to positive outcomes. Data analyses are underway, with drafts of the first several papers being developed. A paper about the resident outcomes was presented at the International Society for the Quality of Life Conference, Toronto, in October 2007. Funding source CHERE staff Collaborators 1. Faculty of Nursing, Midwifery and Health, UTS Medical Services Advisory Committee (MSAC) ApplicationsKey Objectives The role of MSAC is to provide recommendations to the Australian Minister for Health and Ageing regarding the evidence relating to the safety, effectiveness and cost-effectiveness of health technologies and medical procedures. The recommendations of MSAC are used by the Australian federal government to decide whether public funding via MBS should be granted. In 2007, ASERNIP-S and CHERE entered a formalised Memorandum of Understanding, outlining a collaborative approach to undertaking health technology assessments for MSAC. ASERNIP-S and CHERE have been working in collaboration for over 12 months, and this experience has allowed streamlined and cohesive approaches to economic assessment to be developed. Over the past year, we have produced a total of six reviews together for MSAC in what we believe is a successful and positive collaboration. MSAC Applications 2007-(in collaboration with ASERNIP-S) Application 1033 Autologous chondrocyte implantation (protocol) Application 1106 Endoscopic argon plasma coagulation therapy (to be presented to the MSAC executive) Application 1109 Deep brain stimulation for dystonia and essential tremor (current) Application 1113 Endovenous laser treatment for varicose veins (to be presented to the MSAC executive) Application 1115 Sacral nerve stimulation for urinary incontinence (current) Application 1123 Computer-aided total knee arthroplasty (current) Funding source CHERE staff Adolescents and young adults (AYA) with cancer or a blood disorder: Validation of a modified health related quality of life (HRQOL) measure for patient and proxy in an Australian/Australasian contextKey Objectives While there are numerous instruments to measure health related quality of life (HRQOL) in cancer, most of these are designed for adults. The Pediatric Quality of Life Inventory (PedsQL), also called the PedsQL Measurement Model, is a suite of instruments designed to measure health related quality of life (HRQOL) in children and adolescents aged 2-18 years. There are parallel child self-report and parent proxy-report formats, and age-specific versions differing in developmentally appropriate language for ages 2-4 years (toddler, proxy-report only), 5-7 years (young child), 8-12 years (child), and 13-18 years (adolescent). Patient and proxy versions of the PedsQL adolescent forms (13-18 years) were modified for 16-24 year olds. The Memorial Symptom Assessment Scale was used to group patients by symptom severity. Eighty-eight AYA patients aged 16-25 and 79 nominated proxies completed questionnaires. In 2006, these data were analysed. The researchers found that the scales had good internal consistency (Cronbach’s alpha range 0.81 – 0.96). Most scales distinguished between patients with mild, moderate and severe symptoms, confirming clinical validity. The original factor structure was replicated, confirming construct validity. Correlations among scales were as expected, confirming discriminant validity. These modified versions of the PedsQL Generic Core and Cancer Module provide reliable, valid and sensitive measures of HRQOL in AYA with cancer or a blood disorder, suitable for use in clinical trials, research and practice. A paper describing the development and psychometric properties of these instruments is under peer review, and another describing the HRQOL of Australian AYA using these in preparation. The results have been presented at several conferences (International Psycho-Oncology Society World Congress, Venice 2006 and London 2007; the Clinical Oncology Society of Australia conference, Melbourne 2006; and the International Society of Quality of Life Research, Toronto 2007). Funding source CHERE staff Collaborators 1 Department of Mathematical Sciences, UTS Clinical trial of joint mobilisation after ankle fractureKey Objectives Passive joint mobilisation is frequently used by physiotherapists to reduce pain, improve joint movement and facilitate recovery after injury. A multi-centre, assessor-blinded randomised controlled trial was used to evaluate the effectiveness and cost effectiveness of this treatment. 91 patients with ankle fracture have completed the three stages of follow-up over 24 weeks. The primary outcome measures were the Lower Extremity Functional Scale and the Assessment of Quality of Life. Secondary outcome measures included measures of impairment, activity limitation and participation. Cost information from the perspective of the health system and the patient was collected using questionnaires. There were no clinically worthwhile differences in activity limitation or quality of life between groups at any time point. There was also no between-group difference in quality-adjusted life-years, but the treatment group incurred higher out-of-pocket costs (mean between-group difference = AU$200, 95% CI 26 to 432). Two papers have been published (BMC Musculoskeletal Disorders 2006 and Journal of Rehabilitation Medicine, 2008) and a third on the costs and utilization of health services is being prepared. Funding source Motor Accidents Authority of NSW CHERE staff Collaborators 1. University of Sydney Dementia outcomes measurement suiteKey Objectives By developing a set of recommended measures it is hoped to standardise the assessment and evaluation procedures used in this field to enhance comparability of findings across research and practice settings. Work began in May 2006, the first project report was submitted to the Department of Health and Ageing in July 2006, and the second and final report was submitted in February 2007. The latter report contains a chapter on the standardisation of clinical terminology was presented for feedback and consideration, and detailed reviews of assessment tools for the following categories of measures: dementia-specific assessment; dementia-specific quality of life; cognitive assessment; multi-attribute utility; symptoms of dementia; patient and carer satisfaction; generic health related quality of life; functional skills; and other measurement issues (indigenous and cultural issues, proxy issues, tiered assessment, research gaps and implementation issues). Funding source CHERE staff Collaborators 1. Centre for Health Service Development, University of Wollongong DoCs Early Intervention Program “Brighter Futures”Key Objectives The DoCs Brighter Futures program aims to reduce and prevent child-abuse and neglect in at risk families by providing targeted support. The Program is being rolled out over a five year period (2003-2008) under a DoCs $1.2 billion program of reform and renewal. CHERE is working in a consortium comprising: - the University of NSW Social Policy Research Centre, - the University of Western Sydney School of Education and Early Childhood Studies, and - the Southern Cross University, Gnibi College of Indigenous Australian Peoples to design and implement an evaluation framework for the Brighter Futures program. The framework was designed in 2006. Data collection, analysis and reporting has been ongoing in 2007. CHERE will be undertaking the cost-effectiveness and cost-benefit analyses. During 2007, CHERE completed a framework document for the cost-benefit analysis and commenced work on this aspect of the evaluation. Initial data from the prospective evaluation of the costs and effectiveness outcomes has been received and is being evaluated in terms of quality and completeness. Funding source CHERE staff Collaborators 1. Social Policy Research Centre (SPRC) UNSW Cost-effectiveness Analysis of Alternate Strategies to Redress Iodine Deficiency in AustraliaKey Objectives As part of Proposal P230 - Consideration of Mandatory Fortification with Iodine, the Department of Health and Ageing (Australian Government) commissioned CHERE to investigate the cost-effectiveness of alternate strategies to redress iodine deficiency in Australia. The motivation for FSANZ proposal P230 is the re-emergence of iodine deficiency in Australia and New Zealand. We considered alternative approaches to redress iodine deficiency in Australia and New Zealand. These were: a) Maintenance of status quo; Our findings suggest that both the Australian and New Zealand populations are mildly iodine deficient, as defined by the World Health Organization (WHO). After either mandatory or voluntary iodine fortification of bread, we estimate that Australia and New Zealand will become iodine adequate. We also estimate the cost per person (mandatory and voluntary) removed from cohorts with levels below 50 μg/l and 100 μg/l over a ten year period. For mandatory fortification, our estimates suggest that there will be approximately 128,000 and 7,320,000 fewer people with average annual iodine levels of <50 μg/l and <100 μg/l respectively in Australia. The cost-effectiveness ratios, which estimate the costs of reducing the population below 50 μg/l UIC (100 μg/l) by one for a ten-year period are $24.32 ($0.42) for Australia and $4.28 ($0.37) for New Zealand. For voluntary fortification, our estimates suggest that there will be 102,200 and 5,834,000 fewer person with an annual average UIC of <50 μg/l and <100 μg/l respectively in Australia. The cost-effectiveness ratios, which estimate the costs of reducing the population below 50 μg/l UIC (100 μg/l) for a ten-year period are $25.82 ($0.45) for Australia and $4.99 ($0.48) for New Zealand. In comparing voluntary fortification with mandatory fortification, economic evaluation would conventionally exclude voluntary fortification since it is subject to extended dominance. Mandatory fortification has a greater effect in reducing iodine deficiency, and reduces the population at a lower cost per person (despite having a higher overall cost). The findings were submitted in a report to DOHA. Funding source CHERE staff Economic evaluation of genetic screening for haemochromatosisKey Objectives Haemochromatosis is a condition which causes iron overload which, if untreated, leads to clinical symptoms and eventual organ damage. It is an interesting case study as the development of symptoms is linked to a reasonably frequent chromosomal abnormality. Early detection allows monitoring for the development of clinical symptoms, and the treatment, regular blood donation, is effective and non-invasive. Screening is possible by genetic testing or by testing for signs of iron overload. This study is an extension of CHERE’s genetic testing research. This cost-effectiveness analysis of population screening is based on and has been developed with the Victorian Haemscreen program which provides workplace based screening via genetic testing. The has provided estimates of costs, screening behaviours and test results from the Victorian experience. A complex decision model has been constructed which also incorporates natural disease history and treatment effectiveness. Preliminary results have been presented at several conferences. Funding source CHERE staff Collaborators 1. Peninsula Technology Assessment Group (PenTAG) & Institute for Health & Social Care Research Peninsula Medical School Universities of Exeter & Plymouth Economic evaluation of Cystic Fibrosis (CF) screening: a review of the literatureKey objectives Cystic Fibrosis is the most common serious genetic disease in Caucasians with an incidence of 1:2500 and carrier frequency of 1:25. The first component of this research was to test the quality and transferability of the economic literature on carrier screening for CF to any country context. A systematic literature search identified 14 studies focusing on prenatal CF screening between 1990 and 2005. These articles were assessed against international benchmarks on conducting and reporting of economic evaluations, focusing on the transferability of the evidence to any national context. The findings concluded it was not possible to apply existing evidence to the local context. The variability in study design, model inputs and reporting of economic evaluations of CF carrier screening made it difficult to make any economic evidence based recommendations and raises issues on applicability and transferability of such international evidence to any national country contexts. This provided the basis for a successful grant application to Cystic Fibrosis Australia, the aim of which is to model the costs and consequences of screening for CF carrier screening. A CHERE Working Paper has been produced. • Paper published in Health Policy - Citation: Radhakrishnan M, van Gool K, Hall J, Delatycki M, Massie J.Economic evaluation of cystic fibrosis screening: a review of the literature. Health Policy, 2008 Feb; 85(2):133-47. • Decision framework for the cost-effectiveness analysis completed. • Application for data request and Ethical Approval from CF Australia. Awaiting response • Work in Progress o Uptake probabilities being estimated from the genetic screening DCE data o Cost data being collected by investigators at Melbourne Funding Source CHERE staff Collaborators 1. Royal Children’s Hospital, Melbourne Evaluation of the effectiveness of expanded newborn screening by tandem mass spectrometryKey Objectives For over 25 years Australian babies have been tested for up to four treatable metabolic disorders at birth. Recent technological advances using tandem mass spectrometry have made it possible to inexpensively expand this screening to include 30 extremely rare genetic disorders. In collaboration with geneticists and clinicians across Australia, CHERE is examining the costs and consequences of using tandem mass spectrometry to screen for a range of inherited metabolic conditions in newborns compared to detection of the disorders by clinical diagnosis (when symptoms appear). This is the first study of its type to be conducted anywhere in the world. The hypothesis being tested is that early detection of disorders by tandem mass spectrometry will provide medical and cognitive benefits to affected babies not currently achieved by clinical detection, without significant harm. In this study 59 children with Medium Chain Acyl-CoA Dehydrogenase Deficiency (MCADD) were identified (35 unscreened, 2.28/100,000 total population, 24 screened, 5.2/100,000). Before four years of age, three screened MCADD patients experienced a severe illness (including one neonatal death) versus 23 such episodes (and five deaths) in the unscreened group. Unscreened children may be more likely to be admitted to hospital and to incur higher emergency department costs than screened children, while screened children seem more likely to attend hospital outpatient clinics. The incremental cost of screening and subsequent treatment per 100,000 screened infants is $349,000. Current publications are: 1. Wilcken, B., Haas, M., Joy, P., Wiley, V., Chaplin, M., Black, C., Fletcher, J., McGill, J. and Boneh, A., Outcome of neonatal screening for medium-chain acyl-coa dehydrogenase deficiency, Lancet, 369, 9555, pp. 37 - 42, 2007. Funding source CHERE staff Collaborators 1. Children’s Hospital, Westmead Evidence-based interpretation guidelines for health related quality of life (HRQOL) measuresKey Objectives Patients’ perception of their quality of life is an important aspect of cancer treatment. Although it is now a common outcome in clinical trials and health services research, interpretation of the clinical significance of effects from quality of life scales is problematic. The units of measurement are unfamiliar to clinicians and patients alike. Substantial experience with quality of life instruments now provides a rich evidence base for estimating effect sizes and developing interpretation guidelines for quality of life measures. The QLQ-C30 is the core questionnaire of the European Organisation for Research and Treatment of Cancer’s modular approach to Health related Quality of life (HRQOL) assessment. It is the most widely used HRQOL instrument in cancer clinical trials. A literature review has been used to identify papers containing results from different groups of patients or, from patients over time using the QLQ-30. The literature review commenced in 2005 and was completed in June 2007. 330 papers were identified as suitable for inclusion. A panel of over 50 clinicians has been convened to review these papers, to decide on the clinical relevance of each comparison and to predict the size of the effect on quality of life. 94 papers have been reviewed 3 times, 83 have been reviewed twice, and 82 papers have been reviewed once, giving a total reviewed at least once of 259/330 (78%), total reviewed at least twice of 177/330 (54%) and total reviewed three times of 94/330 (29%). We are now focussing on getting 200 papers reviewed twice, and 100 reviewed 3 times. Data entry is underway. The extracted data will be pooled using meta-analysis methods and the evidence used to publish interpretation guidelines. Funding source CHERE staff Collaborators 1. Clinical Trials Research Unit, Universtiy of Leeds, UK Cost-effectiveness Analysis of Iodine Fortification in Australia and New ZealandKey Objectives As part of Proposal P230 - Consideration of Mandatory Fortification with Iodine, Food Standards Australia New Zealand (FSANZ) commissioned CHERE to investigate the cost-effectiveness of iodine fortification of bread in Australia and New Zealand. The motivation for FSANZ proposal P230 is the re-emergence of iodine deficiency in Australia and New Zealand. Iodine is an essential trace element that must be derived exogenously. Iodine is required for the formation of thyroid hormones, which are essential for normal thyroid function, growth and development. The thyroid gland is able to maintain, synthesise and secrete thyroid hormones even during extended periods of excessively low or high iodine intake. However extended periods of relatively high or low iodine intake can lead to illness. Insufficient dietary iodine results in a range of adverse conditions known collectively as Iodine Deficiency Disorders (IDDs). We modelled the distribution of average annual urine iodine content (UIC) in both Australia and New Zealand, stratified into children, pregnant women, and other adults. This modelling accounted for both the median level of UIC and the distribution of iodine levels around this median. Using Tasmanian data on voluntary fortification, we estimated the effect on the median UIC after mandatory fortification is introduced. The results suggest a significant decrease both in the proportion of individuals with iodine levels below 50 μg/l, and in those with levels between 50 μg/l and 100 μg/l. These results are relatively robust to changing the effect of fortification on UIC. Using these data, we then estimated the cost per unit reduction in at-risk populations over a ten year period. Our estimates suggest that there will be 102,509 and 5,912,315 fewer people below 50μg/l and 100μg/l respectively, in Australia. In New Zealand the corresponding figures are 181,709 and 1,901,722 for the <50μg/l and <100μg/l cohorts, respectively. The relatively greater impact in New Zealand reflects the higher severity of iodine deficiency at baseline, and the likelihood of a greater intake of iodised salt bread. Finally, the cost-effectiveness ratios, which estimate the costs of preventing one person from having an iodine level below 50μg/l (100μg/l) are A$104.35 (A$1.81) for Australia and NZ$15.30 (NZ$1.46) for New Zealand. The findings were submitted in a report to FSANZ. Funding source CHERE staff Collaborators Home based rehabilitation program for survivors of a critical illness: a randomised clinical trialKey Objectives Over 130,000 Australians are admitted to intensive care units each year. Whilst survival rates are high, recovery post-discharge is often slow. May patients suffer from de-conditioning as well as psychological distress. This study involves survivors of a critical illness, aged over 18 years, who have spent more than 48 hours in intensive care. Ten intensive care units around Australia are involved in the project which aimed to recruit 200 patients by the end of 2007. Recruits are randomly allocated to either intervention or control. Those allocated to intervention receive an individualised endurance and strength training program conducted at home over an eight-week period. Both the exercise and non-exercise groups are assessed at weeks 1, 8 and 26 (post hospital discharge) to examine physical functioning, exercise capacity, health related quality of life and psychological well-being. Recruitment remains slower than anticipated, commonly because of the requirements for home visits within a 30km radius (now nominal) of the recruitment site, and patients being transferred into the tertiary ICUs from outside local geographical catchment areas. There has been some limited participant drop-out or discontinued intervention to date. An additional clinical site was commenced in October 2007 to optimise recruitment of study participants for the remainder of the grant (Royal Perth Hospital, WA). There are currently 155 participants randomized, with a target of 220. We plan to recruit until mid-2008, and complete participant follow-up by the end of 2008. Funding source CHERE staff Collaborators 1. Faculty of Nursing & Midwifery USYD Health related quality of life (HRQOL) and supportive care needs of men after treatment for early stage prostate cancerObjectives Prostate cancer is second only to lung cancer as the most common cancer in men. The NSW Prostate Cancer Care and Outcomes Study (PCOS) is following a group of men with prostate cancer from diagnosis for up to five years. The original cohort contained 2021 cases recruited via the NSW Central Cancer Registry and 495 age and postcode matched controls. HRQOL is the main outcome of interest, but supportive care needs and coping styles have also been surveyed. HRQOL data are being collected using a telephone administered questionnaire. The University of California LA Prostate Cancer Index (UCLA PCI) and the hormonal domain section of the Expanded Prostate Cancer Index (EPIC) are being used to measure HRQOL at baseline then at 1,2,3 and 5 years after diagnosis. Five-year interviews were completed for all cases by December 2007. When we originally set up this cohort we estimated that approximately 67% of cases would likely be alive and available for their five-year interview, equating to approximately 1,355 interviews. Retention rates in the cohort exceeded our estimates by a considerable amount, to the extent where 80% of cases who were interviewed at baseline undertook a five-year interview (n=1,602). Five-year interviews for controls will be completed in mid 2008. The three-year quality of life data have been cleaned and analysed, and an initial paper drafted. A subsample of the cohort completed a discrete choice experiment of preferences for treatment outcomes. These data have been cleaned and an initial manuscript drafted. A paper describing the unmet supportive care needs in the year following diagnosis was published in the Journal of Clinical Oncology in 2007. The findings show that attention should be given to sexual and psychological needs in the early months after diagnosis or treatment of prostate cancer, particularly in younger men, those with less education, and those having surgery. Funding source CHERE staff Collaborators 1 The Cancer Council New South Wales, Sydney Economic models of cancer treatment protocols (EM-CAP)Key Objective This study will address one of the most enduring problems in health care: the translation of economic evidence into policy and clinical practice. The first aim of the project is to build on the strong clinical evidence available in the Cancer Institute NSW Standard Treatment (CI-SCaT) program, an online resource of more than 200 peer-reviewed cancer treatment guidelines. Researchers will produce and disseminate evidence about the cost effective use of cancer medicines in clinical practice. The systematic approach to development and dissemination of economic models is a world first. The models developed will be similar to those produced by pharmaceutical companies for PBS funding but will be developed transparently and reported with end-users in mind. The second aim of the research is to work with local decision makers to adapt the decision analytic models to the particular context of their locality. Researchers will work with local staff to modify the decision analytic models by combining evidence of effectiveness with local information about prices and costs. Guidelines will be developed to accompany the economic models to support the use of the resource allocation tool in local settings. Factors which influence the cost effectiveness (or cost-ineffectiveness) of cancer medications in different types of treatment settings will be identified. Work in 2007 has focused on developing methodologies for modelling CI-SCAT protocols. A high level framework for the approach to be taken in this project was published in Pharmacoeconomics 25, 12: 1055 -1062, 2007. Funding source CHERE staff Collaborators 1. Prince of Wales Hospital, Sydney Perceptions on health related technology decision making within the Northern Sydney, Central Coast Area Health Service (NSCCAHS)Key Objective This project provided the NSCCAHS with feedback about the factors that influence medical technology decision making and priority setting, and gained insight into changes key stakeholders feel are necessary to improve the current process. During 2006 researchers conducted interviews and surveyed healthcare providers and health service managers, to investigate perceptions and opinions about the current processes and criteria used for the approval and introduction of new technologies at the institutional level. Types of technology include clinical devices, diagnostic/ therapeutic equipment, pharmaceuticals, interventional procedures and health programs. Results suggest current decision making is ad hoc. Clinicians are seen as the drivers for introducing new technology but budgetary impact is the main consideration. There appears to be no formal communication about technology upgrades or discontinued use of medical technology and decision makers are reliant on informal peer group networks for information. A paper was presented at the HSRAANZ Early Careers Workshop, Sydney, in November 2006. An article is currently in press in the journal Australian Health Review. The project was completed and results were feedback to the Area on 27 November 2007. Funding Source CHERE staff Collaborator 1. NSCCAHS Well-being and informal careKey Findings This project used Household Income and Labour Dynamics in Australia (HILDA) data to investigate the impact of care giving on self reported well-being. The HILDA survey of a national representative sample of Australians was conducted in 2001. As part of the survey respondents were asked about their well-being and informal care. The results show that providing informal care has a clear negative effect on well-being, when care is provided to someone of 18 years and older within the same household. Providing informal care to somebody outside of one’s household does not result in well-being losses. The results of this study provide useful new data on informal caregiving in Australia and add to the literature as it compares both caregivers and non-caregivers across a range of dimensions. Funding source CHERE staff Collaborator 1. School of Economics, UNSW |
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