Dataset Information

Microsimulation model for the health economic evaluation of osteoporosis interventions: study protocol.

ABSTRACT:

Introduction

Osteoporosis is a systemic skeletal disease that is characterised by reduced bone strength and increased fracture risk. Osteoporosis-related fractures impose enormous disease and economic burden to the society. Although many treatments and health interventions are proven effective to prevent fractures, health economic evaluation adds evidence to their economic merits. Computer simulation modelling is a useful approach to extrapolate clinical and economic outcomes from clinical trials and it is increasingly used in health economic evaluation. Many osteoporosis health economic models have been developed in the past decades; however, they are limited to academic use and there are no publicly accessible health economic models of osteoporosis.

Methods and analysis

We will develop the Australian osteoporosis health economic model based on our previously published microsimulation model of osteoporosis in the Chinese population. The development of the model will follow the recommendations for the conduct of economic evaluations in osteoporosis by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases and the US branch of the International Osteoporosis Foundation. The model will be a state-transition semi-Markov model with memory. Clinical parameters in the model will be mainly obtained from the Dubbo Osteoporosis Epidemiology Study and the health economic parameters will be collected from the Australian arm of the International Costs and Utilities Related to Osteoporotic Fractures Study. Model transparency and validates will be tested using the recommendations from Good Research Practices in Modelling Task Forces. The model will be used in economic evaluations of osteoporosis interventions including pharmaceutical treatments and primary care interventions. A user-friendly graphical user interface will be developed, which will connect the user to the calculation engine and the results will be generated. The user interface will facilitate the use of our model by people in different sectors.

Ethics and dissemination

No ethical approval is needed for this study. Results of the model validation and future economic evaluation studies will be submitted to journals. The user interface of the health economic model will be publicly available online accompanied with a user manual.

SUBMITTER: Si L

PROVIDER: S-EPMC6398703 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Microsimulation model for the health economic evaluation of osteoporosis interventions: study protocol.

Si Lei L Eisman John A JA Winzenberg Tania T Sanders Kerrie M KM Center Jacqueline R JR Nguyen Tuan V TV Palmer Andrew J AJ

BMJ open 20190218 2

<h4>Introduction</h4>Osteoporosis is a systemic skeletal disease that is characterised by reduced bone strength and increased fracture risk. Osteoporosis-related fractures impose enormous disease and economic burden to the society. Although many treatments and health interventions are proven effective to prevent fractures, health economic evaluation adds evidence to their economic merits. Computer simulation modelling is a useful approach to extrapolate clinical and economic outcomes from clinic ...[more]

PMID: 30782956

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Project description:BackgroundFew simulation models have incorporated the interplay of diabetes, obesity, and cardiovascular disease (CVD); their upstream lifestyle and biological risk factors; and their downstream effects on health disparities and economic consequences.MethodsWe developed and validated a US Diabetes, Obesity, Cardiovascular Disease Microsimulation (DOC-M) model that incorporates demographic, clinical, and lifestyle risk factors to jointly predict overall and racial-ethnic groups-specific obesity, diabetes, CVD, and cause-specific mortality for the US adult population aged 40 to 79 y at baseline. An individualized health care cost prediction model was further developed and integrated. This model incorporates nationally representative data on baseline demographics, lifestyle, health, and cause-specific mortality; dynamic changes in modifiable risk factors over time; and parameter uncertainty using probabilistic distributions. Validation analyses included assessment of 1) population-level risk calibration and 2) individual-level risk discrimination. To illustrate the application of the DOC-M model, we evaluated the long-term cost-effectiveness of a national produce prescription program.ResultsComparing the 15-y model-predicted population risk of primary outcomes among the 2001-2002 National Health and Nutrition Examination Survey (NHANES) cohort with the observed prevalence from age-matched cross-sectional 2003-2016 NHANES cohorts, calibration performance was strong based on observed-to-expected ratio and calibration plot analysis. In most cases, Brier scores fell below 0.0004, indicating a low overall prediction error. Using the Multi-Ethnic Study of Atherosclerosis cohorts, the c-statistics for assessing individual-level risk discrimination were 0.85 to 0.88 for diabetes, 0.93 to 0.95 for obesity, 0.74 to 0.76 for CVD history, and 0.78 to 0.81 for all-cause mortality, both overall and in three racial-ethnic groups. Open-source code for the model was posted at https://github.com/food-price/DOC-M-Model-Development-and-Validation.ConclusionsThe validated DOC-M model can be used to examine health, equity, and the economic impact of health policies and interventions on behavioral and clinical risk factors for obesity, diabetes, and CVD.HighlightsWe developed a novel microsimula'tion model for obesity, diabetes, and CVD, which intersect together and - critically for prevention and treatment interventions - share common lifestyle, biologic, and demographic risk factors.Validation analyses, including assessment of (1) population-level risk calibration and (2) individual-level risk discrimination, showed strong performance across the overall population and three major racial-ethnic groups for 6 outcomes (obesity, diabetes, CVD, and all-cause mortality, CVD- and DM-cause mortality)This paper provides a thorough explanation and documentation of the development and validation process of a novel microsimulation model, along with the open-source code (https://github.com/food-price/ DOCM_validation) for public use, to serve as a guide for future simulation model assessments, validation, and implementation.

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Project description:BACKGROUND:Acute malnutrition is currently divided into severe (SAM) and moderate (MAM) based on level of wasting. SAM and MAM currently have separate treatment protocols and products, managed by separate international agencies. For SAM, the dose of treatment is allocated by the child's weight. A combined and simplified protocol for SAM and MAM, with a standardised dose of ready-to-use therapeutic food (RUTF), is being trialled for non-inferior recovery rates and may be more cost-effective than the current standard protocols for treating SAM and MAM. METHOD:This is the protocol for the economic evaluation of the ComPAS trial, a cluster-randomised controlled, non-inferiority trial that compares a novel combined protocol for treating uncomplicated acute malnutrition compared to the current standard protocol in South Sudan and Kenya. We will calculate the total economic costs of both protocols from a societal perspective, using accounting data, interviews and survey questionnaires. The incremental cost of implementing the combined protocol will be estimated, and all costs and outcomes will be presented as a cost-consequence analysis. Incremental cost-effectiveness ratio will be calculated for primary and secondary outcome, if statistically significant. DISCUSSION:We hypothesise that implementing the combined protocol will be cost-effective due to streamlined logistics at clinic level, reduced length of treatment, especially for MAM, and reduced dosages of RUTF. The findings of this economic evaluation will be important for policymakers, especially given the hypothesised non-inferiority of the main health outcomes. The publication of this protocol aims to improve rigour of conduct and transparency of data collection and analysis. It is also intended to promote inclusion of economic evaluation in other nutrition intervention studies, especially for MAM, and improve comparability with other studies. TRIAL REGISTRATION:ISRCTN 30393230 , date: 16/03/2017.

Project description:BACKGROUND:Health economic evaluations are essential to support health care policy and investment decisions. To date, health economic evaluations in orthotics and prosthetics have focused on discrete components of an orthosis/prosthesis (e.g. a microprocessor controlled prosthetic knee joint) rather than the broader service provided by orthotist/prosthetists. As such, the contribution to orthotic/prosthetic policy and investment decisions is unclear. Whilst there are opportunities to conduct more informative health economic evaluations that describe the costs and benefits of the orthotic/prosthetic service, it is important that prospective research is informed by a critical review of the method design challenges and an understanding of how this research can be improved. The aim of this systematic review is to critically appraise the existing orthotic/prosthetic health economic evaluation literature and therefore determine evidence gaps, critical method design issues and the extent to which the literature informs orthotic/prosthetic policy and investment decisions. METHODS:A comprehensive range of databases-AMED, EMBASE, MEDLINE and PsychINFO, Cumulative Index of Nursing and Allied Health Literature (CINAHL), ProQuest Nursing and Allied Health, Web of Science, Cochrane Database of Systematic Reviews (CDSR) and specialty health economic databases-will be searched using National Library of Medicine Medical Subject Headings (MeSH) terms as well as the title, abstract, and keyword terms. Search terms related to the intervention (e.g. orthosis), including variants used by varying professional disciplines (e.g. brace), will be used in preference to defining the populations that use orthotic and prosthetic services (e.g. people living with rheumatoid arthritis). Search terms related to health economic evaluations will be guided by previously developed and tested search strings and align with recommendations by the Canadian Agency for Drugs and Technologies in Health. Articles meeting the inclusion criteria will be hand-searched for relevant citations, and a forward citation search using Google Scholar will also be conducted to identify early online articles not yet indexed in traditional databases. Original research published in the English language and after 1 January 2000 will be included. The Checklist for Health Economic Evaluation Reporting Standards (CHEERS) and the Consensus on Health Economic Criteria (CHEC)-Extended list will be used to appraise the methodological quality and identify sources of bias. Data extraction and appraisal will be conducted by one reviewer independently using appraisal instrument guidelines and a content specific decision aid with exemplars. A subsequent review by a second researcher will be undertaken to confirm the accuracy of the extraction and appraisal, and a final review by a third where consensus cannot be reached. The data will be extracted to a purpose-built data extraction template with decision-making guidelines to support consistency. Where possible, the findings of the review will be reported as a meta-analysis, although the heterogeneity of the literature will likely mean a narrative review that illuminates method design issues that contribute to imprecision and variation will be more appropriate. DISCUSSION:This protocol has been purposefully designed to summarise the existing evidence and appraise the methodological approaches used and the quality of the health economic evaluations in orthotics and prosthetics. What we learn from this review will be used to guide further work in this area and design more rigorous health economic evaluations into the future. SYSTEMATIC REVIEW REGISTRATION:PROSPERO CRD42018116910.

Project description:BackgroundGlobally, hypertensive disorders of pregnancy, particularly pre-eclampsia and eclampsia, are the leading cause of maternal and neonatal mortality, and impose substantial burdens on the families of pregnant women, their communities, and healthcare systems. The Community Level Interventions for Pre-eclampsia (CLIP) Trial evaluates a package of care applied at both community and primary health centres to reduce maternal and perinatal disabilities and deaths resulting from the failure to identify and manage pre-eclampsia at the community level. Economic evaluation of health interventions can play a pivotal role in priority setting and inform policy decisions for scale-up. At present, there is a paucity of published literature on the methodology of economic evaluation of large, multi-country, community-based interventions in the area of maternal and perinatal health. This study protocol describes the application of methodology for economic evaluation of the CLIP in South Asia and Africa.MethodsA mixed-design approach i.e. cost-effectiveness analysis (CEA) and qualitative thematic analysis will be used alongside the trial to prospectively evaluate the economic impact of CLIP from a societal perspective. Data on health resource utilization, costs, and pregnancy outcomes will be collected through structured questionnaires embedded into the pregnancy surveillance, cross-sectional survey and budgetary reviews. Qualitative data will be collected through focus groups (FGs) with pregnant women, household male-decision makers, care providers, and district level health decision makers. The incremental cost-effectiveness ratio will be calculated for healthcare system and societal perspectives, taking into account the country-specific model inputs (costs and outcome) from the CLIP Trial. Emerging themes from FGs will inform the design of the model, and help to interpret findings of the CEA.DiscussionThe World Health Organization (WHO) strongly recommends cost-effective interventions as a key aspect of achieving Millennium Development Goal (MDG)-5 (i.e. 75 % reduction in maternal mortality from 1990 levels by 2015). To date, most cost-effectiveness studies in this field have focused specifically on the diagnostic and clinical management of pre-eclampsia, yet rarely on community-based interventions in low-and-middle-income countries (LMICs). This study protocol will be of interest to public health scientists and health economists undertaking community-based trials in the area of maternal and perinatal health, particularly in LMICs.Trial registrationClinicalTrials.gov: NCT01911494.

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Project description:Background Produce prescription programs, providing free or discounted produce and nutrition education to patients with diet-related conditions within health care systems, have been shown to improve dietary quality and cardiometabolic risk factors. The potential impact of implementing produce prescription programs for patients with diabetes on long-term health gains, costs, and cost-effectiveness in the United States has not been established. Methods and Results We used a validated state-transition microsimulation model (Diabetes, Obesity, Cardiovascular Disease Microsimulation model), populated with national data of eligible individuals from the National Health and Nutrition Examination Survey 2013 to 2018, further incorporating estimated intervention effects and diet-disease effects from meta-analyses, and policy- and health-related costs from published literature. The model estimated that over a lifetime (mean=25 years), implementing produce prescriptions in 6.5 million US adults with both diabetes and food insecurity (lifetime treatment) would prevent 292 000 (95% uncertainty interval, 143 000-440 000) cardiovascular disease events, generate 260 000 (110000-411 000) quality-adjusted life-years, cost $44.3 billion in implementation costs, and save $39.6 billion ($20.5-58.6 billion) in health care costs and $4.8 billion ($1.84-$7.70 billion) in productivity costs. The program was highly cost effective from a health care perspective (incremental cost-effectiveness ratio: $18 100/quality-adjusted life-years) and cost saving from a societal perspective (net savings: $-0.05 billion). The intervention remained cost effective at shorter time horizons of 5 and 10 years. Results were similar in population subgroups by age, race or ethnicity, education, and baseline insurance status. Conclusions Our model suggests that implementing produce prescriptions among US adults with diabetes and food insecurity would generate substantial health gains and be highly cost effective.

Dataset Information

Microsimulation model for the health economic evaluation of osteoporosis interventions: study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Publications

Microsimulation model for the health economic evaluation of osteoporosis interventions: study protocol.

Similar Datasets

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